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Monthly Update Report for Trials Started in February 2026


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1: Summary data from new trials identified for Leukemia and Lymphoma.


Overview

Number of Trials: 32

These 32 trials investigate treatments for hematologic malignancies, primarily leukemias and lymphomas. Common interventions include CAR T-cell therapies, BTK inhibitors, BCL-2 inhibitors, immunotherapies, and novel targeted agents. Many trials focus on relapsed/refractory disease, measurable residual disease, and post-transplant maintenance. Several trials explore combination therapies, biomarker-driven enrollment, and novel agents without FDA approval. Trials span Phase 1 through Phase 2, with emphasis on safety, tolerability, and preliminary efficacy.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically confirmed diagnosis of hematologic malignancy
  • Relapsed or refractory disease after prior therapy
  • Measurable disease by imaging or flow cytometry
  • ECOG or Karnofsky performance status ≤2
  • Adequate organ function (liver, kidney, cardiac)
  • Adequate hematologic function (ANC, platelets, hemoglobin)
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective contraception
  • Ability to provide informed consent

Common Exclusion

  • Active uncontrolled infection
  • Active CNS involvement by malignancy
  • Pregnant or breastfeeding
  • Active autoimmune disease requiring immunosuppression
  • Prior allogeneic transplant with active GVHD or recent immunosuppression
  • HIV, hepatitis B, or hepatitis C with detectable viral load
  • Concurrent malignancy requiring treatment
  • Recent live vaccine administration
  • Severe cardiac, pulmonary, or hepatic dysfunction
  • Use of strong CYP3A inhibitors or inducers

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07356245

Phase II Study of Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant in T-Cell Lymphoma Genomic-based

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 52-year-old adult with peripheral T-cell lymphoma in complete remission 60 days post-allogeneic stem cell transplant, ECOG status 1, with adequate blood counts and organ function, no active infections or GvHD.

Phase II

Interventions

  • Drug: Ruxolitinib
    Summary: Ruxolitinib is an orally bioavailable JAK1/JAK2 inhibitor that reduces inflammation and cellular proliferation by blocking the JAK-STAT signaling pathway. FDA-approved for myelofibrosis, polycythemia vera, and graft-versus-host disease; used here as maintenance therapy post-transplant in T-cell lymphoma (FDA label, NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for research to analyze genetic and molecular features, aiding in understanding disease mechanisms and developing targeted therapies (NCI Thesaurus).
  • Procedure: Biopsy Procedure
    Summary: Removal of tissue specimens or fluid for microscopic examination to establish diagnosis and guide treatment decisions (NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Removal of bone marrow core tissue containing bone spicules and hematopoietic elements for diagnosis and evaluation of hematologic malignancies including leukemias and lymphomas (NCI Thesaurus).
  • Procedure: Positron emission tomography-computed tomography
    Summary: Imaging method using X-rays and computer reconstruction to create cross-sectional scans for examining internal body structures (NCI Thesaurus).

Key Inclusion

  • Adult patients with T-cell lymphoma in partial or complete remission between day +35 and +120 from auto-SCT or allo-SCT
  • ECOG performance status of 2 or less
  • ANC > 1000/mm3 without G-CSF for at least 3 days
  • Platelets > 50K/mm3 without transfusion for at least 3 days
  • Adequate organ function with bilirubin < 1.5 x ULN and ALT ≤ 3 x ULN
  • CKD-EPI eGFR ≥ 30 ml/min and ejection fraction > 45%
  • Able to tolerate oral or enteral medications

Key Exclusion

  • ALK+ or DUSP22+ ALCL with low IPI score (<2) in first complete remission
  • Progressive disease or systemic therapy post-SCT (radiation allowed)
  • Disease progression to Ruxolitinib previously
  • GvHD requiring systemic therapy
  • Active uncontrolled infections
  • History of veno-occlusive disorder post-transplant
  • Grade ≥ 3 non-hematologic toxicity from SCT not resolved to grade ≤ 2
  • Myocardial infarction or stroke within 1 year of study entry

NCT07192237

Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 42-year-old with Philadelphia chromosome-negative B-cell ALL in morphological remission with persistent MRD at 10-6 sensitivity, ECOG status 1, and no history of CNS pathology or prior subcutaneous blinatumomab therapy.

Phase 2

Interventions

  • Biological: Blinatumomab
    Summary: A bispecific CD19-directed CD3 T-cell engager that binds CD19 on B-cells and CD3 on T-cells, engaging cytotoxic T lymphocytes to eliminate CD19-positive leukemic B-cells. FDA-approved for MRD-positive and relapsed/refractory B-cell ALL. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years with documented B-cell ALL
  • Recurrent or persistent MRD at sensitivity of 10-6
  • Morphological remission (Ph-, Ph+, Ph-like)
  • ECOG performance status 0, 1, or 2
  • Adequate organ function (creatinine ≤1.6 mg/dl, bilirubin ≤3.5 mg/dl, ALT/AST ≤5x ULN)
  • Agreement to use adequate contraception during study and 4 months after completion

Key Exclusion

  • Pregnant or breastfeeding women
  • Symptomatic CNS leukemia
  • History of clinically relevant CNS pathology (epilepsy, seizure, stroke, severe brain injury)
  • Severe (≥grade 3) CNS events including ICANS from prior CAR-T or T-cell engager therapies
  • Active acute or chronic GVHD requiring systemic immunosuppression
  • Prior therapy with subcutaneous blinatumomab for R/R B-cell ALL
  • Known hypersensitivity to blinatumomab
  • Active uncontrolled infection or HIV, HBV, HCV

NCT07222579

A Multicenter Phase II Study of Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

Organization/Sponsor: West Virginia University


Example patient: A 78-year-old patient with newly diagnosed CD19-positive mixed phenotype acute leukemia, ECOG performance status 3, and chronic heart failure with ejection fraction 45%, ineligible for intensive induction chemotherapy.

Phase 2

Interventions

  • Biological: Subcutaneous Blinatumomab
    Summary: A bispecific CD19-directed CD3 T-cell engager that simultaneously binds CD19 on leukemic B cells and CD3 on T cells, redirecting T-cell cytotoxic activity against cancer cells. Approved for CD19-positive B-cell precursor ALL in various settings including MRD-positive and relapsed/refractory disease. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • Histologically or cytologically confirmed MPAL based on 2022 WHO criteria
  • Cohort A: Age ≥75 or comorbidities precluding intensive chemotherapy (CHF, EF ≤50%, DLCO/FEV1 ≤65%, ECOG 3-4, CCI ≥3)
  • Cohort B: CD19+ MPAL in CR/CRh/CRi with MRD ≥0.1% after at least one treatment line
  • Cohort C: Confirmed relapsed/refractory CD19+ MPAL
  • Post-allo-HSCT patients eligible if ≥4 weeks post-infusion, no GVHD >Grade 2, ≥1 week off immunosuppression
  • CNS leukemia allowed if clinically stable and flow cytometric clear CSF within 2 weeks
  • ECOG performance status ≤2 (Cohorts B and C)
  • Adequate organ function: bilirubin ≤2.5 mg/dL, AST/ALT/ALP ≤5x ULN, creatinine ≤3 mg/dL (Cohorts B and C)

Key Exclusion

  • Receiving other investigational agents or concurrent chemotherapy, radiation, or immunotherapy (except corticosteroids or hydroxyurea)
  • Active, uncontrolled infection not under antimicrobial control

NCT07292272

Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study

Organization/Sponsor: University of Nebraska


Example patient: A 62-year-old survivor of chronic lymphocytic leukemia on maintenance therapy with stable cardiac function and no neurodegenerative disease.

Phase N/A

Interventions

  • Behavioral: Virtual Gym Membership
    Summary: Access rights to gym equipment and facilities for physical activity (NCI Thesaurus).
  • Behavioral: Supervised Exercise and Coaching
    Summary: Health professional-designed physical activity regimen to maintain or improve subject health (NCI Thesaurus).

Key Inclusion

  • Age ≥50 years
  • History of hematological malignancy
  • Able to give informed consent

Key Exclusion

  • Receiving intensive induction or consolidation chemotherapy
  • Neurodegenerative disease, stroke, or uncontrolled psychotic disorders in past 3 months
  • Decompensated heart failure, unstable angina, or disorders limiting aerobic exercise
  • Cardiopulmonary test results precluding safe exercise
  • Life expectancy less than 6 months
  • Not planning follow-up at participating center

NCT06871410

CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 52-year-old with relapsed AML after two prior therapies, Karnofsky score 80%, adequate organ function, and an identified potential allogeneic transplant donor.

Phase I

Interventions

  • Biological: Autologous Anti-CD83 CAR T-cells
    Summary: Autologous T-lymphocytes engineered to express a chimeric antigen receptor targeting CD83, which is expressed on AML blasts; upon administration, these CAR T-cells recognize and kill CD83-expressing tumor cells (NCI Thesaurus).
  • Drug: Fludarabine Phosphate
    Summary: A fluorinated nucleoside analog that inhibits DNA synthesis through its metabolite fludarabine triphosphate, used for lymphodepletion prior to CAR T-cell infusion (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: An alkylating agent that cross-links DNA to disrupt cancer cell replication, used for lymphodepletion conditioning before CAR T-cell therapy (FDA label, NCI Thesaurus).
  • Drug: Hydroxyurea
    Summary: An antimetabolite that inhibits ribonucleotide reductase to reduce DNA synthesis, used to control blast counts in chronic myeloid leukemia and other malignancies (FDA label, NCI Thesaurus).
  • Procedure: Leukapheresis
    Summary: A procedure that collects white blood cells from peripheral blood for CAR T-cell manufacturing while returning the rest to the donor (NCI Thesaurus).
  • Procedure: Lumbar Puncture
    Summary: An invasive procedure to access cerebrospinal fluid for diagnostic testing to check for CNS involvement in leukemia (NCI Thesaurus).
  • Diagnostic Test: Positron Emission Tomography
    Summary: Uses radioactive tracers to visualize metabolic activity in tissues, helping evaluate treatment response and identify disease spread (NCI Thesaurus).
  • Diagnostic Test: Computed Tomography
    Summary: X-ray imaging that constructs cross-sectional scans to monitor tumor progression and assess treatment effectiveness (NCI Thesaurus).
  • Diagnostic Test: Echocardiography
    Summary: Uses high-frequency sound waves to create images of heart structures, assessing cardiac function before CAR T-cell therapy (NCI Thesaurus).
  • Diagnostic Test: Chest Radiography
    Summary: An x-ray examination of the chest for baseline and safety monitoring (NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing and research to analyze disease characteristics and treatment response (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Having individuals complete questionnaires to assess patient-reported outcomes and quality of life (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years old
  • Relapsed or refractory AML based upon ELN 2022 criteria
  • Karnofsky performance status ≥70%
  • Creatinine clearance ≥40 mL/min
  • Left ventricular ejection fraction >45%
  • Absolute lymphocyte count ≥0.2 x 10^9/L
  • Preliminarily eligible for allogeneic hematopoietic cell transplantation
  • If prior allogeneic HCT, must be ≥3 months post-transplant, off immunosuppression ≥2 weeks, and no active GVHD

Key Exclusion

  • Acute promyelocytic leukemia (APL; AML M3)
  • Active central nervous system leukemia
  • Systemic glucocorticoid use >10 mg daily prednisone equivalent at apheresis or within 4 weeks of CAR T infusion
  • Active grade II-IV acute GVHD requiring treatment
  • HIV seropositivity or active hepatitis B or C infection
  • Prior solid organ transplant
  • Active autoimmune disease requiring immunosuppressive therapy
  • Pregnant or nursing females

NCT07302776

TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Organization/Sponsor: Stanford University


Example patient: A 52-year-old patient with AML in complete remission, Karnofsky score 80%, normal renal and cardiac function, scheduled for first allogeneic transplant with an 8/8 HLA-matched sibling donor, no prior transplant history or active infections.

Phase N/A

Interventions

  • Drug: Early Tacrolimus Taper Strategy
    Summary: A strategy involving gradual cessation of tacrolimus, a calcineurin-inhibitor immunosuppressant that prevents T-cell activation by inhibiting calcineurin phosphatase, used to prevent graft-versus-host disease in allogeneic transplant recipients (FDA label, NCI Thesaurus).
  • Drug: Tacrolimus
    Summary: A macrolide calcineurin-inhibitor that binds FKBP-12 protein to suppress T-lymphocyte activation and cytokine production, indicated for preventing organ rejection in allogeneic transplants with monitoring for infection, malignancy, and nephrotoxicity risks (FDA label, NCI Thesaurus).

Key Inclusion

  • AML in CR, CRi, or MLFS
  • MDS with IPSS-M or IPSS-R intermediate or higher
  • Myelofibrosis
  • Age 18-80 years
  • First allogeneic transplant with 8/8 HLA matched donor
  • eGFR ≥50 mL/min or creatinine <2 mg/dL
  • Cardiac ejection fraction ≥45%
  • Karnofsky Performance Score ≥70%

Key Exclusion

  • Prior allogeneic HCT
  • Positive anti-donor HLA antibodies with MFI >1000
  • Uncontrolled bacterial, viral, or fungal infections
  • Seropositive for HIV, HTLV, Hepatitis B sAg, or Hepatitis C antibody with detectable viral load
  • Known allergy to PTCy or tacrolimus
  • Uncontrolled autoimmune disease requiring immunosuppression
  • Concurrent malignancy diagnosed within 12 months
  • Unwilling to use birth control for one year post-transplant

NCT07052305

A Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old patient with relapsed diffuse large B-cell lymphoma after two prior therapies, ECOG performance status 1, with measurable FDG-avid disease on PET/CT, adequate organ function, and no CNS involvement, eligible for axicabtagene ciloleucel CAR T-cell therapy.

Phase 1

Interventions

  • BLA: CAR T-cell therapy
    Summary: CD19-directed CAR T-cell immunotherapy that harvests patient T cells, genetically modifies them to express a chimeric antigen receptor targeting CD19-expressing cancer cells, and reinfuses them to eliminate tumor cells; indicated for relapsed/refractory large B-cell lymphoma and follicular lymphoma (FDA label, NCI Thesaurus).
  • Biological: NT-I7
    Summary: Long-acting recombinant human IL-7 fused to hybrid Fc region that stimulates proliferation, differentiation, and survival of T-cell subsets including naive, central memory, effector memory, and NK T-cells, enhancing anti-tumor immune responses with extended half-life (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed relapsed or refractory large B-cell lymphoma including DLBCL NOS, high grade B-cell lymphoma, DLBCL from indolent lymphoma, grade 3B follicular lymphoma, primary mediastinal large B-cell lymphoma
  • Measurable disease by IWG response criteria with FDG-avid lesions on PET/CT
  • Eligible for FDA-approved SOC CD19 CAR T-cell therapy (axi-cel or liso-cel)
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Adequate bone marrow function: ANC ≥ 1.0 K/cumm, platelets ≥ 50 K/cumm, hemoglobin ≥ 8.0 g/dL
  • Adequate organ function: creatinine clearance ≥ 30 mL/min, total bilirubin ≤ 1.5 x IULN, AST/ALT ≤ 2.5 x IULN
  • QTcF < 500 ms on ECG

Key Exclusion

  • Previous allogeneic solid organ or bone marrow transplant
  • Documented active CNS involvement by lymphoma
  • Chemotherapy, biologic, or hormonal therapy within 14 days prior to first NT-I7 injection
  • Uncontrolled intercurrent illness including active infection, congestive heart failure NYHA Class ≥ 2, uncontrolled atrial fibrillation
  • Cardiac events within 6 months: myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting
  • History of autoimmune disease within past 2 years (with specified exceptions)
  • Pregnant or breastfeeding
  • HIV-infected without effective anti-retroviral therapy and undetectable viral load for 6 months

NCT07148180

A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax Genomic-based

Organization/Sponsor: Dana-Farber Cancer Institute


Example patient: A 62-year-old man with secondary AML in complete remission with CD123-positive measurable residual disease at 0.3% by flow cytometry, ECOG status 1, adequate organ function, and no prior allogeneic transplant.

Phase 1, Phase 2

Interventions

  • Drug: Venetoclax
    Summary: Venetoclax is an orally bioavailable BCL-2 inhibitor that induces apoptosis in cancer cells by binding to BCL-2 protein and restoring apoptotic processes. It is FDA-approved for CLL, SLL, and newly diagnosed AML in combination with hypomethylating agents in elderly or unfit patients. Source: FDA label, NCI Thesaurus.
  • Drug: Azacitidine
    Summary: Azacitidine is a nucleoside metabolic inhibitor that suppresses abnormal hematopoietic cell proliferation by inhibiting nucleic acid synthesis. It is FDA-approved for treating MDS subtypes and juvenile myelomonocytic leukemia, administered subcutaneously or intravenously. Source: FDA label.
  • Biological: Tagraxofusp
    Summary: Tagraxofusp-erzs is a CD123-directed cytotoxin fusion protein combining interleukin-3 and diphtheria toxin fragment that binds CD123 receptors and delivers cytotoxic payload causing ADP-ribosylation of EF-2 and protein synthesis inhibition. FDA-approved for blastic plasmacytoid dendritic cell neoplasm in adults and pediatric patients. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Diagnosis of Acute Myeloid Leukemia (de novo, secondary, or arising from MDS)
  • In CR, CRi, or CRh with <5% morphologic blasts in bone marrow
  • CD123+ by central assessment
  • Measurable residual disease ≥0.1% by multiparametric flow cytometry
  • ECOG performance status ≤2
  • Adequate organ function (bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN, creatinine clearance ≥45 ml/min)
  • Albumin ≥3.2 g/dL

Key Exclusion

  • Prior CD123-targeted therapy
  • Acute promyelocytic leukemia
  • Intensive chemotherapy within 2 weeks or venetoclax within 5 days
  • History of prior allogeneic stem cell transplant
  • Grade 3 or 4 capillary leak syndrome history
  • Concurrent malignancy or prior malignancy within 6 months
  • Active/symptomatic CNS involvement
  • Moderate or strong CYP3A inducers within 7 days

NCT07025564

A Phase 1 Trial of miRisten in Adult Patients With Relapsed/Refractory AML

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old patient with relapsed AML after two prior therapies, ECOG status 1, adequate organ function, no active infections, and no recent stem cell transplant.

Phase 1

Interventions

  • Drug: miR-126 Inhibitor miRisten
    Summary: An antisense oligodeoxynucleotide that inhibits microRNA miR-126 in leukemia stem cells and endothelial cells, disrupting LSC self-renewal, downregulating BCL-2, and inducing apoptosis via mitochondrial dysfunction and increased reactive oxygen species. Source: NCI Thesaurus.
  • Procedure: Echocardiography Test
    Summary: Ultrasound imaging procedure to monitor cardiac function and detect therapy-related cardiac dysfunction, particularly important for surveillance during cancer treatment. Source: NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for research analysis to understand cancer mechanisms and support development of targeted therapies. Source: NCI Thesaurus.

Key Inclusion

  • Age 18 years or older
  • Histologically confirmed relapsed or refractory AML per ICC or WHO criteria
  • Failed or ineligible for available AML therapies
  • ECOG performance status 0-2
  • Life expectancy at least 3 months
  • Adequate organ function: bilirubin ≤1.5x ULN, AST/ALT ≤3x ULN, creatinine clearance ≥60 mL/min
  • LVEF ≥45% and QTcF ≤480 ms
  • Recovered from prior therapy toxicity to grade 1 or less

Key Exclusion

  • Allogeneic stem cell transplant within 3 months or on calcineurin inhibitors within 2 weeks
  • Chemotherapy, radiation, or immunotherapy within 14 days except hydroxyurea
  • Acute promyelocytic leukemia
  • Systemic steroids >10 mg/day prednisone equivalent within 14 days
  • Strong or moderate CYP3A4 inducers or strong CYP3A inhibitors within 7 days
  • Unstable cardiac disease or acute coronary syndrome within 6 months
  • Uncontrolled active infection or clinically significant uncontrolled illness
  • Other active malignancy that may interfere with study assessment

NCT07400029

A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 45-year-old with CD19-positive Ph-negative B-cell ALL in MRD-negative first complete remission after HyperCVAD induction, ECOG 1, with adequate organ function and no extramedullary disease.

Phase II

Interventions

  • Biological: Obecabtagene Autoleucel
    Summary: CD19-directed CAR-T cell immunotherapy using autologous T cells genetically modified with a lentiviral vector expressing CAT-41BBz CAR with 4-1BB costimulatory domain. Targets CD19-positive B-cell leukemia cells, inducing cytotoxic response and tumor lysis. FDA-approved for relapsed/refractory B-cell precursor ALL. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • CD19+ B-cell ALL (Ph-negative or Ph-positive)
  • Age ≥40 years, or 30-39 with high-risk comorbidities or poor chemotherapy tolerability
  • MRD-negative CR or CRi (MRD <10^-4 by flow cytometry or molecular testing)
  • Within 4 months from initiation of frontline treatment
  • CD19 expression documented at any time since diagnosis
  • CNS1 status at screening
  • ECOG performance status 0-2
  • Adequate organ function (ALT/AST ≤5x ULN, creatinine <2.0mg/dL, LVEF ≥50%)

Key Exclusion

  • Burkitt's leukemia or lymphoma
  • Measurable extramedullary disease at screening
  • Concurrent active malignancy (except non-melanoma skin cancer)
  • Uncontrolled systemic infection at leukapheresis or CAR-T infusion
  • Active HIV, Hepatitis B, Hepatitis C, HTLV, or Syphilis infection
  • Blinatumomab as bridging therapy post-apheresis
  • Therapeutic corticosteroids within specified timeframes
  • Prior CNS2/CNS3 disease without CNS1 clearance and symptom resolution

NCT07130695

Olutasidenib Single Agent as Maintenance Therapy in IDH1mut AML After Induction and Consolidation Genomic-based

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 52-year-old man with IDH1-mutant AML who achieved complete response after intensive induction chemotherapy 45 days ago, with ECOG status 1 and adequate organ function, not planning stem cell transplant.

Phase N/A

Interventions

  • Drug: Olutasidenib
    Summary: Olutasidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor that blocks mutated IDH1 enzyme activity, reducing leukemic cell proliferation in IDH1-mutant acute myeloid leukemia. FDA-approved for relapsed/refractory AML with susceptible IDH1 mutations detected by FDA-approved testing. Sources: FDA label, NCI Thesaurus.

Key Inclusion

  • IDH1 mutant acute myeloid leukemia confirmed histologically or cytologically
  • Completed induction and/or consolidation achieving CR, CRh, CRi, or MLFS
  • Within 90 days of last cycle of upfront therapy
  • Age ≥18 years
  • Creatinine clearance ≥30 mL/min
  • ECOG 0-2 or KPS >50%
  • Able to take oral medications

Key Exclusion

  • History of hypersensitivity to olutasidenib
  • QTc >450 ms or history of Torsades de Pointes
  • Stem cell transplant planned within 60 days
  • Received non-intensive upfront therapy including HMA/Venetoclax
  • Currently receiving other targeted or AML-directed therapies
  • Pregnant or nursing women
  • Systemic corticosteroids above 10mg/day prednisone equivalent
  • Other investigational agents within 4 weeks

NCT07164469

Phase 2 Trial of CD70.CAR NK Cells for Patients With Primary Refractory or Early Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 42-year-old woman with primary refractory DLBCL showing CD70 expression of 35% on tumor biopsy, ECOG PS 1, with hypermetabolic mediastinal and abdominal lymph nodes on PET/CT, adequate organ function, and no active infections.

Phase 2

Interventions

  • Biological: CD70.CAR NK Cells
    Summary: Allogeneic natural killer cells engineered with anti-CD70 CAR and TGFBR2 gene deletion to target CD70-expressing tumor cells while resisting TGF-beta-mediated inactivation, enhancing anti-tumor activity (NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent that cross-links DNA to inhibit replication, used for lymphodepletion prior to CAR-NK cell infusion in lymphomas and leukemias (FDA label, NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog that inhibits DNA synthesis via DNA polymerase and ribonucleotide reductase inhibition, used for lymphodepletion in CLL and lymphomas (FDA label, NCI Thesaurus).
  • Drug: Rimiducid (AP1903)
    Summary: Lipid-permeable tacrolimus analogue that homodimerizes modified FKBP12 domains in engineered receptors, serving as a safety switch to eliminate CAR-NK cells if needed (NCI Thesaurus).

Key Inclusion

  • Age 18-75 years
  • Primary refractory or early relapsed (≤12 months) classical Hodgkin lymphoma or DLBCL
  • Tumor CD70 expression ≥10% by immunohistochemistry or flow cytometry
  • Measurable hypermetabolic disease on PET/CT
  • ECOG performance status ≤2
  • Adequate organ function (creatinine clearance ≥30 ml/min, LVEF ≥40%, pulmonary function ≥50%)
  • Adequate blood counts (WBC >2K, platelets >50K)
  • Effective contraception required for women of childbearing potential and men

Key Exclusion

  • Lymphoma in complete remission with no measurable disease
  • Active hepatitis B viremia or hepatitis C with detectable viral load
  • HIV infection
  • Active CNS involvement or untreated brain metastases
  • Grade ≥3 non-hematologic toxicity from prior therapy not improved to ≤grade 2
  • Anti-cancer treatment within 2 weeks of enrollment
  • Systemic steroid therapy at enrollment (except physiological replacement)
  • Active infection requiring parenteral antibiotics

NCT07166419

Phase I Clinical Trial of Caring Cross Anti-CD19/20/22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) (C3PO) Genomic-based

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 52-year-old with relapsed diffuse large B-cell lymphoma after failing rituximab-chemotherapy and autologous stem cell transplant, with CD19/CD20-positive disease, ECOG 1, and adequate organ function.

Phase I

Interventions

  • Biological: Autologous Anti-CD19/CD20/CD22 CAR T-cells
    Summary: Autologous T-cells engineered with a CAR targeting CD19, CD20, and CD22 tumor antigens; induces selective toxicity in B-cell malignancies expressing these markers (NCI Thesaurus).
  • Drug: Fludarabine
    Summary: Fluorinated nucleoside analog inhibiting DNA polymerase and ribonucleotide reductase; used for lymphodepleting chemotherapy in CLL and lymphoma (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent cross-linking DNA to disrupt replication; used for lymphodepleting chemotherapy in lymphomas, leukemias, and solid tumors (FDA label, NCI Thesaurus).
  • Procedure: Pheresis
    Summary: Procedure collecting peripheral blood components (T-cells) while returning remainder to donor for CAR T-cell manufacturing (NCI Thesaurus).
  • Diagnostic: Positron Emission Tomography
    Summary: Imaging using radioactive tracers (e.g., FDG) to visualize metabolic activity; evaluates treatment response and disease burden (NCI Thesaurus).
  • Diagnostic: Computed Tomography
    Summary: X-ray imaging constructing cross-sectional scans; monitors tumor progression and treatment effectiveness (NCI Thesaurus).
  • Diagnostic: Echocardiography Test
    Summary: Ultrasound imaging of heart function; monitors cardiac toxicity from chemotherapy, especially anthracyclines (NCI Thesaurus).
  • Diagnostic: Multigated Acquisition Scan
    Summary: Radionuclide imaging measuring left ventricular ejection fraction; evaluates cardiac function and treatment-related cardiotoxicity (NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Removal of bone marrow core tissue for microscopic analysis; diagnoses and evaluates hematologic malignancies and disease progression (NCI Thesaurus).
  • Procedure: Bone Marrow Aspiration
    Summary: Needle aspiration of bone marrow cells; evaluates hematologic disorders, infections, and cytogenetics (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for research; analyzes genetic and molecular features to understand disease mechanisms (NCI Thesaurus).

Key Inclusion

  • Relapsed or refractory non-Hodgkin lymphoma, acute lymphoblastic leukemia, or chronic lymphocytic leukemia
  • At least 2 prior lines of therapy
  • CLL patients must have received BTK inhibitor and venetoclax
  • Tumor positive for CD19 and/or CD20 and/or CD22
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate organ function (liver, kidney, cardiac LVEF ≥40%, pulmonary O2 ≥92%)
  • Absolute lymphocyte count ≥100/uL

Key Exclusion

  • Autologous transplant within 6 weeks or allogeneic transplant within 2 months
  • Active CNS or meningeal involvement by lymphoma or leukemia
  • Active graft versus host disease
  • Untreated brain metastases
  • Active malignancy other than non-melanoma skin cancer or carcinoma in situ
  • Uncontrolled infection or intercurrent illness
  • Pregnant or breastfeeding
  • History of autoimmune disease requiring immunosuppression within 6 months

NCT07402876

A Prospective, Randomized, Double-masked, Dosing-frequency-controlled, Multicenter Clinical Trial Evaluating the Safety and Activity of Intravitreally Injected ADX-2191 (Methotrexate Injection USP) in Patients With Primary Vitreoretinal Lymphoma

Organization/Sponsor: Aldeyra Therapeutics, Inc.


Example patient: A 58-year-old male with biopsy-confirmed primary vitreoretinal lymphoma and lymphomatous vitreous cells on screening, no methotrexate allergy, and no recent systemic methotrexate use.

Phase N/A

Interventions

  • Drug: Monthly ADX-2191 injection
    Summary: Methotrexate injection administered monthly via intravitreal route for primary vitreoretinal lymphoma, utilizing anti-proliferative effects to target lymphomatous cells in the eye (Summary of Web Search).
  • Drug: ICM ADX-2191 injection
    Summary: Investigational methotrexate formulation delivered intravitreally for primary vitreoretinal lymphoma, inhibiting folate-dependent enzymes to suppress lymphomatous vitreous cells (Summary of Web Search).

Key Inclusion

  • 21 years old or older
  • Biopsy proven primary vitreoretinal lymphoma
  • Presence of lymphomatous vitreous cells at screening or vitrectomized eye confirming diagnosis
  • Willingness to sign informed consent

Key Exclusion

  • Known allergy or hypersensitivity to methotrexate
  • Planned eye surgery during the clinical trial
  • Women of childbearing potential who are pregnant or lactating
  • Pre-existing ocular or non-ocular conditions interfering with trial conduct or interpretation
  • Use of systemic methotrexate within one week prior to treatment

NCT07222631

An Open-Label, First-in-Human Phase 1/2, Dose-Escalation and Dose-Expansion/ Combination Therapy Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SB-4826 as a Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphomas and in Combination With Rituximab in Adult Participants With Non-Hodgkin Lymphomas

Organization/Sponsor: University of California, San Diego


Example patient: A 52-year-old with relapsed follicular non-Hodgkin lymphoma after two prior therapies, presenting with progressive bulky nodal disease, ECOG status 1, adequate organ function, and no active infections or cardiovascular disease.

Phase 1, Phase 2

Interventions

  • Biological: Rituximab
    Summary: Rituximab is a chimeric monoclonal antibody targeting CD20 antigen on B cells, inducing cytotoxicity through complement-dependent and antibody-dependent mechanisms for treating CD20-positive non-Hodgkin lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: SB-4826
    Summary: SB-4826 is an investigational oral agent targeting specific cancer pathways, being studied for safety and efficacy in non-Hodgkin lymphoma and solid tumors (Summary of Web Search).

Key Inclusion

  • Aged 18 and older
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor or non-Hodgkin lymphomas
  • Malignancy has relapsed after, progressed on, is not a candidate for, is intolerant of, or refuses standard of care therapies
  • Adequate hematologic parameters: hemoglobin ≥8 g/dL, ANC ≥1000/microliter, platelets ≥50,000/microliter
  • Adequate organ function: creatinine clearance ≥60 mL/min, ALT/AST ≤1.5x ULN, total bilirubin ≤1.5x ULN
  • Life expectancy ≥3 months
  • ECOG Performance Status ≤2
  • Phase 2: Patients must be planned to receive rituximab as standard of care treatment for NHL

Key Exclusion

  • Use of systemic cancer therapy within 21 days or 5 half-lives
  • Clinically significant cardiovascular disease within 6 months
  • History of chronic liver disease including active viral hepatitis, drug/alcohol-related liver disease, or metabolic dysfunction-associated steatohepatitis
  • Active hepatitis B or hepatitis C infection regardless of viremia
  • Active autoimmune disease requiring >10 mg prednisone daily or immunosuppression
  • Use of CYP3A4/5 sensitive substrates, inhibitors, or inducers within 14 days or 5 half-lives
  • History of Grade 3 or higher immune mediated adverse events from prior immunotherapy
  • Known active central nervous system metastases

NCT06510309

A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma

Organization/Sponsor: Beth Israel Deaconess Medical Center


Example patient: A 52-year-old treatment-naive patient with biopsy-confirmed marginal zone lymphoma, ECOG status 1, with a 2.5 cm cervical lymph node, adequate organ function, and no prior systemic therapy.

Phase 2

Interventions

  • Biological: Rituximab
    Summary: Rituximab is a chimeric monoclonal antibody targeting CD20 antigen on B cells, inducing apoptosis through complement-dependent and antibody-dependent cellular cytotoxicity. It is FDA-approved for CD20-positive B-cell malignancies including non-Hodgkin's lymphoma and chronic lymphocytic leukemia. Source: FDA label, NCI Thesaurus.
  • Drug: Venetoclax
    Summary: Venetoclax is an orally bioavailable BCL-2 inhibitor that induces apoptosis by binding to BCL-2 protein and restoring apoptotic processes in tumor cells. It is FDA-approved for chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia in combination therapy. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Histologically confirmed Marginal Zone Lymphoma
  • Measurable disease with at least one lymph node ≥1.5 cm or spleen >13 cm
  • Age ≥18 years
  • ECOG performance status ≤1
  • Hemoglobin ≥8.0 g/dL, ANC ≥1,000 cells/mcL, platelets ≥50,000 cells/mm3
  • Gastric MALT lymphoma patients must be H. pylori negative or failed eradication
  • Life expectancy greater than 2 years
  • Ability to swallow pills

Key Exclusion

  • Prior systemic therapy including rituximab
  • Prior treatment with ibrutinib or other BTK inhibitor
  • H. pylori-associated gastric MALT or stage I/II MZL unless unfit for radiation
  • Uncontrolled hepatitis B, C, or HIV infection with detectable viral load
  • Pregnant or unwilling to use contraception for 12 months after rituximab
  • Received moderate or strong CYP3A inhibitors within 7 days of venetoclax
  • Received moderate or strong CYP3A inducers within 7 days of venetoclax
  • Uncontrolled intercurrent illness or active infection

NCT07283094

FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia Genomic-based

Organization/Sponsor: Montefiore Medical Center


Example patient: A 78-year-old patient with newly diagnosed adverse-risk AML per 2022 ELN criteria, ECOG PS 2, LVEF 45%, refusing intensive chemotherapy, with 15% bone marrow blasts and adequate organ function.

Phase N/A

Interventions

  • Drug: FHD-286
    Summary: Orally bioavailable allosteric inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2), targeting SWI/SNF chromatin remodeling complexes to disrupt oncogenic transcriptional programs and inhibit tumor cell proliferation (NCI Thesaurus).
  • Drug: Venetoclax
    Summary: Selective BCL-2 inhibitor that induces apoptosis in cancer cells by binding to BCL-2 protein, FDA-approved for CLL, SLL, and newly diagnosed AML in combination with hypomethylating agents (FDA label, NCI Thesaurus).
  • Drug: Decitabine
    Summary: DNA methyltransferase inhibitor that demethylates DNA and reactivates tumor suppressor genes, used to treat myelodysplastic syndromes and acute myeloid leukemia (Summary of Web Search).

Key Inclusion

  • Newly diagnosed adverse risk AML per 2022 ELN criteria or AML progressed after 1 prior line with ≥5% blasts
  • Aged ≥75 years, or 18-74 years refusing or ineligible for intensive induction chemotherapy
  • Bone marrow blasts ≥10% for newly diagnosed AML
  • ECOG PS ≤2 for age ≥75, ≤3 for age 18-74 or relapsed/refractory AML
  • Life expectancy ≥3 months
  • Adequate hepatic function with bilirubin ≤3.0×ULN
  • GFR ≥30 mL/min
  • LVEF ≥40% by echocardiogram

Key Exclusion

  • Acute promyelocytic leukemia
  • Core binding factor AML eligible for intensive chemotherapy
  • CNS involvement with leukemia
  • Prior treatment with azacitidine, decitabine, venetoclax, or FHD-286 (except for relapsed/refractory patients)
  • QTcF >470 milliseconds or uncontrolled cardiac arrhythmia
  • Decompensated liver cirrhosis (Child-Pugh ≥12 or MELD ≥21)
  • Strong CYP3A inhibitors or inducers without appropriate washout
  • Active uncontrolled HIV, hepatitis B, or hepatitis C infection

NCT07206121

A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

Organization/Sponsor: Innoblative Designs, Inc.


Example patient: A 62-year-old woman with a 2.5cm ER/PR+ Her2neu- infiltrating ductal carcinoma, Zubrod status 1, no lymphadenopathy, no cardiac arrhythmia, and no implantable devices.

Phase N/A

Interventions

  • Device: Radiofrequency ablation Electrosurgical Device
    Summary: Radiofrequency ablation uses high-frequency electrical currents to destroy tumor cells by inducing coagulation necrosis through heat generation. It is being studied as an adjunct to breast conserving surgery for early-stage breast cancer. Source: NCI Thesaurus and Web Search.
  • Procedure: Radiofrequency ablation alone
    Summary: Radiofrequency ablation targets tumors by heating them to over 60°C using electrical energy delivered via electrode to induce coagulation necrosis. Explored alone or combined with other treatments for breast cancer. Source: NCI Thesaurus and Web Search.

Key Inclusion

  • Biologic female 50 years of age and older
  • Confirmed infiltrating ductal carcinoma
  • ER/PR+ Her2neu- breast cancer
  • Unicentric, unilateral tumor size ≤3cm
  • Tumor location ≥2cm from skin and other structures
  • No palpable lymphadenopathy
  • Zubrod Performance Status 0, 1, or 2

Key Exclusion

  • Pregnant or breastfeeding
  • Neoadjuvant chemotherapy
  • Cardiac arrhythmia
  • Active implantable medical devices such as pacemakers or defibrillators
  • Current or history of breast implants
  • Multi-centric or bilateral breast cancer
  • Diffuse microcalcifications

NCT07382817

A Phase 1 Safety and Efficacy Study of JV-394 Autologous Anti-CD94 Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed or Refractory CD94+ T/NK Cell Neoplasms Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 52-year-old patient with relapsed extranodal NK/T-cell lymphoma after two prior therapies, ECOG status 1, with 65% CD94-positive tumor cells by IHC and measurable disease on CT scan.

Phase 1

Interventions

  • CAR-T Cell Therapy: JV-394
    Summary: JV-394 is an autologous CAR-T cell therapy targeting CD94 antigen on malignant T/NK cells, engineered from patient's own T cells to recognize and attack CD94-positive cancer cells in relapsed or refractory T-cell lymphomas (Source: Web Search).

Key Inclusion

  • Age ≥18 years
  • Confirmed T/NK cell malignancies
  • Relapsed or refractory disease after at least one line of systemic therapy
  • ≥50% of tumor cells positive for CD94 by flow cytometry or IHC
  • ECOG performance status 0-1
  • At least one measurable lesion per Lugano 2014 or Olsen 2021 criteria
  • Absolute neutrophil count ≥1.0×10⁹/L
  • Cardiac ejection fraction ≥45%

Key Exclusion

  • Aggressive NK cell leukemia or indolent T/NK cell malignancies (TLGL or NK-LGL)
  • Tumor cells in peripheral blood ≥1% of lymphocytes
  • Active CNS lymphoma or detectable cerebrospinal fluid malignant cells
  • Allogeneic cell transplantation within 3 months or active GVHD
  • Class III or IV heart failure within past 6 months
  • Uncontrolled infection requiring IV antimicrobials
  • Active autoimmune or inflammatory disease requiring systemic immunosuppression
  • Cardiac atrial or ventricular lymphoma involvement

NCT07254793

A Feasibility/Pilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation

Organization/Sponsor: University of Arizona


Example patient: A 42-year-old male with relapsed acute myeloid leukemia post-matched sibling HCT, Karnofsky score 70%, no active GvHD, with a 35-year-old sibling donor able to perform exercise testing.

Phase N/A

Interventions

  • Biological: Standard Therapeutic DLI
    Summary: Standard donor lymphocyte infusion uses donor T-cells to induce graft-versus-tumor effect targeting residual leukemia or lymphoma cells post-transplant, though it may cause graft-versus-host disease (Summary of Web Search).
  • Biological: Exercise Mobilized Therapeutic DLI
    Summary: Exercise-enhanced donor lymphocyte infusion mobilizes NK-cells and T-cells with increased anti-tumor activity to treat leukemia and lymphoma relapse post-transplantation (Summary of Web Search).
  • Biological: Standard Prophylactic DLI
    Summary: Prophylactic donor lymphocyte infusion prevents leukemia or lymphoma relapse in high-risk patients by activating immune system to destroy residual malignant cells post-transplant (Summary of Web Search).
  • Biological: Exercise Mobilized Prophylactic DLI
    Summary: Exercise-enhanced prophylactic donor lymphocyte infusion improves immune response against leukemia relapse post-HCT by mobilizing enhanced donor lymphocytes, currently under clinical evaluation (Summary of Web Search).

Key Inclusion

  • Acute leukemia (lymphoid, myeloid or undifferentiated), MDS, CML or NHL
  • Undergoing myeloablative or reduced intensity matched sibling or haploidentical HCT
  • Age 0-65 years for recipients
  • Locally available healthy matched or haploidentical related donor age 12-50 years
  • Donor able to complete fitness evaluation for VO2max and peak cycling power

Key Exclusion

  • Acute grade III-IV aGvHD or moderate/severe chronic GvHD
  • Requiring immunosuppression therapy for GvHD treatment
  • AST/ALT >5x ULN or Bilirubin >2x ULN
  • Creatinine >2x ULN or GFR <40 ml/min/1.73m2
  • DLCO <40% or O2 Sat <92%
  • LVEF <35%
  • Karnofsky score <60% or Lansky score <50%
  • Uncontrolled or severe infection

NCT07290309

Efficacy of a Group-based Videoconference Intervention to Increase Physical Activity in Cancer Survivors

Organization/Sponsor: Colorado State University


Example patient: A 58-year-old English-speaking woman with stage II breast cancer who completed chemotherapy and radiation 8 months ago, currently on aromatase inhibitor therapy, sedentary with controlled blood pressure, and able to walk independently.

Phase N/A

Interventions

  • Behavioral: Asynchronous Group
    Summary: Pre-recorded exercise videos providing aerobic and strength exercises via remote monitoring and telehealth supervision to improve physical fitness and health outcomes in cancer patients (Summary of Web Search).
  • Behavioral: Virtually Supervised Exercise Sessions
    Summary: Live online group exercise classes targeting fatigue reduction and physical fitness improvement to enhance quality of life in cancer patients (Summary of Web Search).

Key Inclusion

  • Able to speak/read English
  • Diagnosed with any type of cancer within the last 5 years
  • Completed primary or adjuvant treatment (chemotherapy, radiation therapy, surgery)
  • No planned treatment within the next nine months
  • Long-term therapies such as anti-hormone or targeted therapies allowed

Key Exclusion

  • Existing participation in ≥150 minutes per week of moderate intensity aerobic exercise
  • Uncontrolled hypertension
  • Inability to walk without an assistive device
  • Current or planned participation in another structured exercise program

NCT07249528

Voice as a Digital Biomarker of Neurotoxicity in CAR T-Cell Therapy

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 52-year-old English-speaking patient with relapsed multiple myeloma, ECOG status 1, owns a smartphone, and is scheduled to receive ide-cel CAR T-cell therapy without any speech or hearing impairments.

Phase N/A

Interventions

  • Diagnostic: Audio Tasks
    Summary: Digital voice recording tasks performed twice daily via smartphone to monitor for neurotoxicity in patients receiving CAR T-cell therapy; source: Web Search.

Key Inclusion

  • Pathologically confirmed non-Hodgkin lymphoma or multiple myeloma
  • Scheduled to receive FDA-approved CAR-T product (Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel)
  • Age ≥ 18 years
  • ECOG Performance Status ≤ 2
  • Smartphone ownership and ability to perform twice daily voice recordings
  • Sufficient English proficiency for structured voice tasks
  • Ability to undergo daily neurologic assessments (ICE score, tremor evaluation)
  • No pre-existing neurological conditions significantly impairing speech

Key Exclusion

  • Pre-existing neurological conditions significantly impairing speech (severe dysarthria, expressive aphasia, neurodegenerative disorders)
  • History of significant speech or voice disorders (laryngeal paralysis, severe dysphonia)
  • Recent vocal cord surgery or radiation to the area
  • Vocal cord pathology (paralysis, chronic laryngitis, nodules, polyps, granulomas, malignancies)
  • Severe hearing impairment interfering with voice assessments
  • Language barriers preventing reliable task completion or data interpretation

NCT06859008

Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old Hispanic woman with relapsed diffuse large B-cell lymphoma after three prior therapies including CAR-T, with measurable lymphadenopathy, ECOG 1, adequate organ function, and no CNS involvement.

Phase N/A

Interventions

  • Drug: Zanubrutinib
    Summary: Zanubrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK-mediated B-cell receptor signaling, inhibiting proliferation and survival of malignant B-cells. FDA-approved for mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, CLL/SLL, and follicular lymphoma. Source: FDA label, NCI Thesaurus.
  • Drug: Sonrotoclax
    Summary: Sonrotoclax is an oral BCL-2 inhibitor that binds and inhibits the anti-apoptotic protein BCL-2, restoring apoptosis in BCL-2-overexpressing tumor cells. Investigational next-generation BCL-2 inhibitor for relapsed/refractory B-cell malignancies. Source: NCI Thesaurus, Web Search.
  • Procedure: Questionnaire Administration
    Summary: Administration of questionnaires to collect patient-reported outcomes and quality of life data. Source: NCI Thesaurus.
  • Procedure: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed internal organ images for disease diagnosis and monitoring. Source: NCI Thesaurus.
  • Procedure: Computed Tomography
    Summary: X-ray imaging technique using computer reconstruction to create cross-sectional body scans for tumor assessment and monitoring. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Biopsy
    Summary: Removal of bone marrow core tissue for microscopic analysis to diagnose and evaluate hematopoietic disorders and tumor spread. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Aspiration
    Summary: Needle aspiration of bone marrow to collect immature hematopoietic cells for evaluation of blood disorders and infections. Source: NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for testing, research, and molecular analysis. Source: NCI Thesaurus.
  • Procedure: Biopsy
    Summary: Removal of tissue or fluid specimens for microscopic examination to establish diagnosis. Source: NCI Thesaurus.

Key Inclusion

  • Age ≥18 years with ECOG ≤2
  • Focus on underrepresented racial/ethnic minorities (Black, Hispanic, Native American, Pacific Islander)
  • R/R DLBCL after ≥2 prior therapies or newly diagnosed/R/R FL, MZL, MCL, CLL/SLL after ≥1 prior therapy
  • Measurable disease by CT/MRI or flow cytometry
  • ANC ≥1,000/mm³ without marrow involvement or ≥500/mm³ with involvement
  • Platelets ≥75,000/mm³ without marrow involvement or ≥30,000/mm³ with involvement
  • Creatinine clearance ≥30 mL/min
  • Negative HIV, HBV, HCV or undetectable viral load if seropositive

Key Exclusion

  • Prior BCL-2 inhibitor therapy ≥2 months or progression on venetoclax
  • Major surgery within 4 weeks or CAR-T/autologous transplant within 30 days
  • Active GVHD or immunosuppression for allogeneic transplant
  • CNS involvement by lymphoma/leukemia
  • Myocardial infarction within 6 months or NYHA class III-IV heart failure
  • Stroke or intracranial hemorrhage within 6 months
  • Prior malignancy within 3 years except specified low-risk cancers
  • Requires strong CYP3A inducers or warfarin

NCT07270978

Phase Ib Study of Anti-CD3 x Anti-CD33 Bispecific Antibody (CD33Bi) Armed Fresh Peripheral Blood Mononuclear Cells (CD33 FPBMC) in Patients With Measurable Residual Disease (MRD)+ Acute Myeloid Leukemia or Myelodysplastic Syndrome Genomic-based

Organization/Sponsor: University of Virginia


Example patient: A 62-year-old male with relapsed AML after venetoclax and azacitidine therapy, ECOG 1, with 8% bone marrow blasts positive for CD33 by flow cytometry and persistent FLT3-ITD mutation indicating MRD positivity.

Phase 1

Interventions

  • Biological: CD33 FPBMC
    Summary: CD33 FPBMC consists of fresh peripheral blood mononuclear cells armed with anti-CD3 x anti-CD33 bispecific antibody, targeting CD33-expressing cells in AML and MDS to enhance immune cell-mediated attack against leukemia cells. Source: Web Search Summary.

Key Inclusion

  • Adults ≥18 years of age
  • Newly diagnosed or relapsed/refractory AML with prior intensive or non-intensive therapy
  • Relapsed/refractory MDS with at least 2 prior cycles of hypomethylating agent and venetoclax or 4 cycles single agent
  • AML patients with MRD positivity defined by blasts ≥5% and/or flow cytometry ≥0.1% and/or persistent mutations/cytogenetics
  • Residual blasts must be CD33 positive at any level
  • LVEF ≥45% at rest
  • ECOG performance status ≤2
  • Effective contraception during treatment plus 90 days

Key Exclusion

  • Pregnancy or lactation
  • Prior treatment with anti-CD33 therapy
  • Active graft versus host disease requiring systemic immunosuppression within 4 weeks
  • AST or ALT >3x ULN or total bilirubin >1.5x ULN
  • Absolute lymphocyte count <300 cells/microliter
  • Creatinine clearance <30 mL/min
  • Known HIV with detectable viral load or active hepatitis B or C
  • Blasts ≥25%

NCT06863402

Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study

Organization/Sponsor: Roswell Park Cancer Institute


Example patient: A 62-year-old patient with biopsy-confirmed Richter transformation to diffuse large B-cell lymphoma from chronic lymphocytic leukemia, ECOG status 1, who progressed after initial chemoimmunotherapy and has measurable disease on PET scan with adequate organ function.

Phase II

Interventions

  • Drug: Nemtabrutinib
    Summary: Nemtabrutinib is an orally available reversible Bruton's tyrosine kinase (BTK) inhibitor that targets both wild-type and C481S mutant BTK, blocking B-cell receptor signaling pathways to inhibit malignant B-cell growth in hematologic malignancies (NCI Thesaurus).
  • Drug: Pembrolizumab
    Summary: Pembrolizumab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1 receptor on T-cells, preventing ligand binding and enhancing immune-mediated tumor destruction; FDA-approved for multiple solid and hematologic malignancies (FDA label, NCI Thesaurus).
  • Procedure: Positron Emission Tomography
    Summary: PET imaging uses radioactive tracers to visualize metabolic activity in tissues, commonly using FDG to detect cancer and evaluate treatment response (NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: CT scanning uses X-rays and computer processing to create cross-sectional images for monitoring tumor progression and treatment effectiveness (NCI Thesaurus).
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue containing bone and hematopoietic elements for diagnosis and evaluation of hematologic disorders including leukemias and lymphomas (NCI Thesaurus).
  • Procedure: Echocardiography
    Summary: Echocardiography uses high-frequency sound waves to create images of heart structures for cardiac function assessment (NCI Thesaurus).
  • Procedure: Multigated Acquisition Scan
    Summary: MUGA scan evaluates ventricular pumping function using radioactive tracer and gamma camera with gated image acquisition to monitor cardiotoxicity during cancer treatment (NCI Thesaurus).
  • Other: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for testing, diagnostic, and research purposes to analyze disease mechanisms (NCI Thesaurus).
  • Other: Questionnaire Administration
    Summary: Administration of questionnaires to assess patient-reported outcomes including quality of life and treatment effects (NCI Thesaurus).

Key Inclusion

  • Biopsy-proven Richter transformation diffuse large B-cell lymphoma from CLL/SLL
  • Ineligible for frontline anthracycline-based chemoimmunotherapy or disease progression after prior RT-DLBCL treatment
  • Measurable disease by PET/CT, immunohistochemistry, or flow cytometry per Cheson criteria
  • Age 18 years or older with ECOG performance status 0-2
  • ANC ≥500 cells/µL, platelets ≥25,000/µL, hemoglobin ≥7 g/dL
  • Creatinine clearance ≥30 mL/min, total bilirubin ≤1.5x ULN
  • AST/ALT ≤2.5x ULN (≤5x ULN with liver metastases)
  • Ability to swallow and retain oral medication

Key Exclusion

  • Prior anti-PD-1, anti-PD-L1, or other T-cell checkpoint inhibitor therapy
  • Systemic anti-cancer therapy within 5 half-lives or 30 days for cellular/investigational agents
  • Chronic systemic steroid therapy exceeding 10 mg prednisone equivalent within 7 days
  • Active CNS metastases or carcinomatous meningitis requiring treatment
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • History of non-infectious pneumonitis requiring steroids or current pneumonitis
  • QTc prolongation (QTcF >450 msec) or significant ECG abnormalities
  • Strong CYP3A4 inhibitors/inducers or P-gp/BCRP substrates with narrow therapeutic index within 14 days

NCT07465835

A Study of ELA026 in Participants With Relapsed/Refractory (R/R) T/NK Cell Malignancies (TCMs)

Organization/Sponsor: Electra Therapeutics Inc.


Example patient: A 52-year-old man with relapsed peripheral T-cell lymphoma after three prior therapies, ECOG 1, with measurable lymphadenopathy on CT scan and no active HLH.

Phase N/A

Interventions

  • Biological: ELA026
    Summary: A human IgG1 monoclonal antibody targeting SIRP family proteins on myeloids and T-lymphocytes to deplete pathological immune cells driving inflammation in T/NK cell malignancies, without inhibiting SIRPalpha/CD47 checkpoint (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Confirmed histologic diagnosis of T/NK cell malignancy
  • Relapsed/refractory following any prior therapy line
  • CTCLs must have received at least 2 prior systemic therapy lines
  • Measurable disease by clinical exam, imaging, or bone marrow
  • ECOG performance score ≤2
  • Life expectancy >6 months

Key Exclusion

  • Eligible for standard of care or approved R/R TCM therapies
  • Organ dysfunction per protocol
  • Hemophagocytic lymphohistiocytosis by HLH2004 criteria
  • Receiving or planning immunotherapy or immune effector cell therapy
  • Allogeneic stem cell transplant within 100 days on immunosuppression
  • Women planning pregnancy or breastfeeding during study plus 60 days
  • Male partners of childbearing-potential women planning pregnancy during study plus 60 days

NCT07049432

A Phase I Study of N-803 Maintenance Therapy Following CD19 Directed CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (CARMEN-803 Trial)

Organization/Sponsor: University of Utah


Example patient: A 52-year-old man with relapsed B-cell NHL who achieved partial response 30 days after receiving commercial CD19 CAR T-cell therapy, with ECOG status 1, adequate organ function, no active infections, and resolved cytokine release syndrome.

Phase I

Interventions

  • Biological: N803
    Summary: N803 is an IL-15 superagonist complex that enhances immune responses by boosting natural killer cells and other immune functions to improve efficacy of CAR T-cell therapies in B-cell non-Hodgkin's lymphoma (Source: Web Search).

Key Inclusion

  • Aged ≥18 years
  • Histologically confirmed B-cell NHL
  • Received commercially approved CD19-directed CAR T-cell therapy per FDA label
  • Achieving CR or PR per Lugano Criteria on D+30 post-CAR-T
  • ECOG Performance Status ≤2
  • ANC ≥750 cells/mm3, platelets ≥50,000 cells/mm3, hemoglobin ≥7 g/dL
  • CRS and ICANS grade 0 at enrollment, off steroids, ≥7 days from tocilizumab
  • Adequate hepatic and renal function

Key Exclusion

  • Prior therapy with N-803, IL-2, or IL-15 based therapy
  • Receiving other investigational agents
  • Autoimmune disease requiring active treatment (except hypothyroidism, diabetes type 1)
  • Cardiovascular disorders including stroke within 6 months, MI within 3 months, LVEF <40%
  • Known HIV infection
  • Active hepatitis B or hepatitis C infection
  • Uncontrolled systemic infection
  • Known severe hypersensitivity to investigational product (Grade ≥3)

NCT07042438

A Phase 2 Randomized Trial of Remodeling Intestinal Microbiota Using Fecal Microbiome Transplant (FMT) Among Recipients of Chimeric Antigen Receptor T Cells (CAR T) Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 52-year-old man with relapsed diffuse large B-cell lymphoma after two prior therapies, KPS 70, who received piperacillin-tazobactam for pneumonia 60 days ago and is scheduled for YESCARTA CAR T-cell therapy.

Phase 2

Interventions

  • Procedure: Placebo Administration
    Summary: Medically inactive substance used as control to evaluate treatment efficacy by comparing outcomes against no active treatment (NCI Thesaurus).
  • Procedure: Leukapheresis
    Summary: Procedure that collects white blood cells from peripheral blood for CAR T-cell therapy by filtering blood to separate leukocytes (NCI Thesaurus).
  • Biological: Fecal Microbiota Transplantation
    Summary: Live microbial suspension from healthy donor stool administered to restore gut microbiome balance, primarily for recurrent C. difficile infections, being studied to improve CAR T outcomes (FDA label, NCI Thesaurus).
  • Drug: Chemotherapy
    Summary: Synthetic or naturally-occurring chemicals that target rapidly dividing cancer cells by interfering with DNA and cell division (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering tissue and fluid samples for testing, research, and analysis of genetic and molecular features (NCI Thesaurus).
  • Biological: Axicabtagene Ciloleucel
    Summary: CD19-directed CAR T-cell immunotherapy using genetically modified autologous T cells with anti-CD19 scFv, CD28, and CD3 zeta domains to target and eliminate CD19-expressing B-cell lymphomas (FDA label, NCI Thesaurus).

Key Inclusion

  • Age 18 years or older
  • Karnofsky performance status 60 or greater
  • Relapsed/refractory CD19 B-cell lymphomas (DLBCL, transformed follicular lymphoma, or double-hit lymphoma)
  • Scheduled to receive commercial YESCARTA CAR T treatment
  • Exposure to high-risk broad-spectrum antibiotics within 90 days of consent
  • Seronegative for HIV, HCV, and active HBV
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective birth control through 12 months after last dose

Key Exclusion

  • Major surgery within 4 months of enrollment
  • Live vaccine within 30 days prior to enrollment
  • History of inflammatory bowel disorder or irritable bowel disorder
  • History of chronic aspiration
  • Diagnosis of primary immunodeficiency
  • Active second malignancy requiring treatment
  • Uncontrolled bacterial, fungal, or viral infection requiring IV antimicrobials
  • Behavioral or neurocognitive disorders interfering with study compliance

NCT06675123

A Pilot Study of Pacritinib Combined With a BTK Inhibitor in Patients With Relapsed/Refractory Mantle Cell Lymphoma Genomic-based

Organization/Sponsor: City of Hope Medical Center


Example patient: A 62-year-old man with relapsed CD5+/CD20+/cyclin D1+ mantle cell lymphoma previously responsive to ibrutinib now showing progressive disease with enlarged lymph nodes measuring 2.5 cm, ECOG 1, adequate organ function, and no bleeding disorders.

Phase N/A

Interventions

  • Drug: Pacritinib
    Summary: Pacritinib is an oral JAK2 and FLT3 kinase inhibitor that blocks JAK-STAT signaling to induce apoptosis in cancer cells. FDA-approved for myelofibrosis with low platelet counts, it is being studied in combination with BTK inhibitors for mantle cell lymphoma. Source: FDA label and NCI Thesaurus.
  • Drug: BTK Inhibitor
    Summary: BTK inhibitors block Bruton tyrosine kinase to inhibit B-cell receptor signaling, treating B-cell malignancies like mantle cell lymphoma. Patients must be on single-agent covalent BTK inhibitors like ibrutinib, acalabrutinib, or zanubrutinib. Source: NCI Thesaurus.
  • Procedure: Positron Emission Tomography
    Summary: PET imaging uses radioactive tracers like FDG to visualize metabolic activity and detect cancer. Used to evaluate treatment response and disease progression in lymphoma. Source: NCI Thesaurus.
  • Procedure: Computed Tomography
    Summary: CT scans use X-rays to create cross-sectional images for monitoring tumor progression and treatment response. Used for disease assessment per Lugano criteria. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Biopsy
    Summary: Bone marrow biopsy removes core tissue containing bone and marrow for microscopic analysis to diagnose and evaluate hematologic malignancies. Used to assess bone marrow involvement in mantle cell lymphoma. Source: NCI Thesaurus.
  • Procedure: Bone Marrow Aspiration
    Summary: Bone marrow aspiration extracts immature hematopoietic cells and blood from bone marrow for diagnostic evaluation. Used to assess disease involvement and cytogenetics. Source: NCI Thesaurus.
  • Procedure: Biopsy
    Summary: Biopsy removes tissue or fluid samples for microscopic examination to establish diagnosis. Fresh tumor biopsies required prior to study therapy for correlative studies. Source: NCI Thesaurus.
  • Other: Biospecimen Collection
    Summary: Collection of tissue and fluid samples for research to analyze genetic and molecular features. Used for correlative studies in this trial. Source: NCI Thesaurus.

Key Inclusion

  • Histologically confirmed mantle cell lymphoma with CD5+, CD20+, cyclin D1+ or t(11,14) translocation
  • Relapsed or refractory disease after at least 1 prior systemic therapy
  • Currently receiving single-agent covalent BTK inhibitor with prior CR or PR, now with progressive disease
  • Radiographically measurable disease by Lugano criteria (nodal ≥1.5 cm or extranodal ≥1.0 cm)
  • Age ≥18 years with ECOG performance status ≤2
  • ANC ≥1000/mm³ without marrow involvement or ≥500/mm³ with marrow involvement
  • Platelets ≥75,000/mm³ without marrow involvement or ≥25,000/mm³ with marrow involvement
  • Creatinine clearance ≥30 mL/min and LVEF ≥50%

Key Exclusion

  • Prior allogeneic stem cell transplant or autologous transplant within 3 months
  • Prior treatment with pacritinib or JAK2 inhibitor, or concomitant pirtobrutinib
  • Strong CYP3A4 inducers/inhibitors or medications increasing bleeding risk within 14 days
  • Significant bleeding history (grade ≥2) within 3 months or known bleeding disorders
  • Clinically significant cardiovascular disease including MI within 3 months or NYHA class III/IV heart failure
  • Active CNS lymphoma involvement or history of progressive multifocal leukoencephalopathy
  • Active uncontrolled infection or known active HBV, HCV, or HIV with detectable viral load
  • Pregnant or breastfeeding women

NCT07226843

NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies

Organization/Sponsor: Eli Lilly and Company


Example patient: A 58-year-old adult with relapsed diffuse large B-cell lymphoma after three prior treatment lines, measurable disease on imaging, no CNS involvement, negative for CMV, hepatitis B/C, and HIV, with normal cardiac function.

Phase 1

Interventions

  • Biological: Rituximab
    Summary: Chimeric monoclonal antibody targeting CD20 antigen on B cells, inducing cytotoxicity through complement-dependent and antibody-dependent mechanisms for treating CD20-positive B-cell malignancies including non-Hodgkin lymphoma and chronic lymphocytic leukemia (FDA label, NCI Thesaurus).
  • Drug: LY4584180
    Summary: Investigational agent targeting BCL6 to disrupt its function and induce apoptosis in hematologic malignancies, specifically lymphoma, currently under evaluation for safety and efficacy (Summary of Web Search).

Key Inclusion

  • Diffuse large B-cell lymphoma - not otherwise specified
  • High-grade B-cell lymphoma
  • Follicular large B-cell lymphoma
  • Follicular lymphoma
  • Other non-Hodgkin lymphoma
  • At least 2 prior lines of systemic therapy or not eligible for available therapy
  • Measurable disease
  • Discontinued all previous cancer treatments and recovered from immediate effects

Key Exclusion

  • Active second cancer
  • Known or suspected central nervous system involvement
  • Known Cytomegalovirus infection
  • Known hepatitis B or C infection
  • HIV infection
  • Significant heart disease

NCT07271667

A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies Genomic-based

Organization/Sponsor: Curis, Inc.


Example patient: A 62-year-old male with CLL on zanubrutinib for 18 months showing partial response but remaining MRD-positive by ClonoSEQ assay, ECOG status 1, without TP53 mutations or 17p deletion.

Phase 2

Interventions

  • Drug: Zanubrutinib
    Summary: Zanubrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK-mediated B-cell receptor signaling, inhibiting proliferation and survival of malignant B-cells. FDA-approved for multiple B-cell malignancies including CLL/SLL, mantle cell lymphoma, and Waldenström's macroglobulinemia. Source: FDA label, NCI Thesaurus.
  • Drug: Emavusertib
    Summary: Emavusertib is an orally bioavailable IRAK4 inhibitor that blocks IRAK4-mediated NF-kB signaling, reducing inflammatory cytokines and pro-survival factors. Targets tumors with MYD88 mutations or overactivated TLR pathways, inhibiting proliferation of IRAK4-overactivated tumor cells. Source: NCI Thesaurus.

Key Inclusion

  • Adults ≥18 years with histopathologically confirmed CLL per WHO 2016 classification
  • At least 1 criterion for measurable disease per iwCLL
  • Cohort 1: PR or PR-L with MRD+ on zanubrutinib for ≥12 months
  • Cohort 2: Relapsed disease with direct progression on zanubrutinib within 3 months
  • Life expectancy ≥3 months
  • ECOG Performance Status 0, 1, or 2
  • Acceptable organ function and CPK <2.5× ULN
  • Ability to tolerate contrast-enhanced CT scan

Key Exclusion

  • High-risk CLL with TP53 mutations and 17p deletion
  • Prior CAR-T cell therapy
  • Active second malignancy requiring systemic therapy
  • History of Grade ≥3 rhabdomyolysis without complete recovery
  • Active systemic infection including HIV, HBV DNA positive, or HCV with cirrhosis
  • Stroke or intracranial hemorrhage within 6 months
  • Anticoagulation with warfarin or dual antiplatelet agents
  • Pregnant or lactating females

NCT06345027

Chimeric Antigen Receptor Treatment Targeting CD70 (SEVENTY) Genomic-based

Organization/Sponsor: Baylor College of Medicine


Example patient: A 52-year-old man with relapsed AML after two cycles of induction chemotherapy, with 68% CD70-positive blasts by flow cytometry, FLT3-mutated disease refractory to midostaurin, Karnofsky score of 70%, and an identified matched unrelated donor for potential subsequent transplant.

Phase N/A

Interventions

  • Biological: CD70-targeted CAR T-cell therapy
    Summary: Chimeric antigen receptor T-cell therapy targeting CD70, a surface antigen expressed on leukemia cells, designed to recognize and eliminate CD70-positive malignant cells in refractory or relapsed leukemias (NCI Thesaurus).

Key Inclusion

  • Primary refractory or relapsed AML (excluding APL) or other CD70+ leukemia
  • CD70 positive leukemia with at least 26% CD70+ cells by flow cytometry or immunohistochemistry
  • Age ≤75 years (first 3 patients ≥18 years)
  • Failed or ineligible for targeted therapies (FLT3, IDH inhibitors, anti-CD33)
  • CD19+ leukemia patients must have failed or be ineligible for commercial CD19 CAR-T
  • Suitable allogeneic HSCT donor identified or patient declines HSCT
  • Karnofsky/Lansky score ≥60%
  • Estimated GFR ≥60 ml/min

Key Exclusion

  • Acute promyelocytic leukemia (APL)
  • Active uncontrolled bacterial, fungal, or viral infection
  • CNS disease with detectable cerebrospinal blast cells
  • Acute GVHD ≥Grade 2 or moderate to severe chronic GVHD
  • Cardiac echocardiography with LVEF <50% or NYHA class III/IV dysfunction
  • High dose steroids >0.5 mg/kg/day prednisone equivalent
  • Hyperleukocytosis (WBC ≥50K) or rapidly progressive disease
  • Pregnant or lactating