drugset / Trial / NCT06046040
TmPSMA-02 in mCRPC
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
Timeline
- Start
- 2024-01-31
- Primary completion
- 2027-01-31
- Completion
- 2042-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TmPSMA-02 CAR T Cells | Cell therapy | 1e+07 cells | Intravenous |
| Subject | TmPSMA-02 CAR T Cells | Cell therapy | 5e+07 cells | Intravenous |
| Subject | TmPSMA-02 CAR T Cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | TmPSMA-02 CAR T Cells | Cell therapy | 3e+08 cells | Intravenous |