Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
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.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous BCMA/CD19 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous BCMA/CD38 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous BCMA/GPRC5D dual-target CAR-T | Cell therapy | — | Other |
| Subject | Autologous CD19/CD20 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous CD19/CD22 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous CD33/CD123 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous CD33/CLL1 dual-target CAR-T module | Cell therapy | — | Other |
| Subject | Autologous CD5/CD7 dual-target CAR-T module | Cell therapy | — | Other |