NCT07523555 Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 96 participants in total. It began in 2026-03-02 with a primary completion date of 2027-03-14.

Brief Summary

Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response. Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.

Eligibility Criteria

Inclusion Criteria: * Age 18 to 75 years at the time of consent. * Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma. * Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator. * Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review. * Measurable or otherwise evaluable disease by disease-specific response criteria. * ECOG performance status 0 to 2. * Adequate organ function: LVEF \>= 45%; creatinine clearance \>= 40 mL/min; AST/ALT \<= 3 x ULN; total bilirubin \<= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation \>= 92% on room air. * Adequate hematologic reserve unless cytopenia is clearly disease-related. * Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up. * If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement. * Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods. * Written informed consent obtained before any study-specific procedure. Exclusion Criteria: * \- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis. * Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol. * Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \>= Grade 3 toxicity from prior anticancer therapy * Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk. * Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy. * Prior solid organ transplant. * Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months. * Uncontrolled HIV, HBV, or HCV viremia. * Pregnancy or breastfeeding. * Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions. * Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients. * Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria. * Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.

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