drugset / Trial / NCT04795882
A New Study Evaluating the Activity of Modular CAR T for mYeloma
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.
Timeline
- Start
- 2022-04-22
- Primary completion
- 2029-03-31
- Completion
- 2029-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCMA CAR-T cells | Cell therapy | 5e+07 cells | Other |
| Subject | BCMA CAR-T cells | Cell therapy | 1.5e+08 cells | Other |
| Subject | BCMA CAR-T cells | Cell therapy | 4.5e+08 cells | Other |
| Subject | BCMA/CD19 CAR T cells | Cell therapy | 5e+07 cells | Other |
| Subject | BCMA/CD19 CAR T cells | Cell therapy | 1.5e+08 cells | Other |
| Subject | BCMA/CD19 CAR T cells | Cell therapy | 4.5e+08 cells | Other |