Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies (NCT07523555) | Clinical Trial Compass
RecruitingPhase 1/2
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
China96 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs) by module and dose level
Timeframe: 28 days
2
Incidence of Grade 3 or higher cytokine release syndrome (CRS)