drugset / Trial / NCT03711864

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

NCT03711864 ↗

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

EvaluationDrugModalityDoseRoute
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 — —

Indications