drugset / Trial / NCT03711864
Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma
Phase 1
Unknown
15 enrolled
Peking Union Medical College Hospital
Beijing Immunochina Medical Science & Technology Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10\^5 / kg, 1 x 10\^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).
Timeline
- Start
- 2019-02-25
- Primary completion
- 2021-10-10
- Completion
- 2021-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IM21 CAR-T cells | Cell therapy | 500000 cells/kg | — |
| Subject | IM21 CAR-T cells | Cell therapy | 1e+06 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |