drugset / Trial / NCT07022964
CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
Phase 1/2
Recruiting
36 enrolled
Beijing GoBroad Hospital
Ruijin Hospital · collabShanghai Liquan Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2026-06-01
- Completion
- 2028-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD5 CAR T-cells | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |