drugset / Trial / NCT05150522

B Cell Maturation Antigen Targeted CAR-T Cells in Treatment With Relapsed and Refractory Multiple Myeloma

NCT05150522

Phase 1/2 Unknown 10 enrolled Shenzhen University General Hospital
NaSingle-groupOpen-labelTreatment

Summary

For the treatment of relapsed and refractory MM, the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma pointed out that relapsed MM is highly heterogeneous, and individualized evaluation of relapsed patients is required to determine the treatment time. Patients with biochemical recurrence with only elevated M protein do not need immediate treatment, only regular follow-up visits. For patients with CRAB manifestations or rapid biochemical relapse, treatment needs to be initiated immediately. Patients who relapse within 6 months can switch to a drug combination with other mechanisms of action; patients who relapse within 6 to 12 months should first switch to a drug combination with other mechanisms of action, or they can be retreated with the original drug; 12 months Patients with the above recurrence can use the original regimen to re-induction therapy, or switch to a drug regimen with other mechanisms of action. Bortezomib, lenalidomide, and thalidomide are currently the key drugs for the treatment of relapsed MM in China. Patients with suitable conditions should undergo autologous hematopoietic stem cell transplantation, while allogeneic hematopoietic stem cell transplantation is rarely used because of higher transplant-related mortality.

Timeline

Start
2021-07-01
Primary completion
2024-07
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject BCMA CAR-T cells Cell therapy

Indications