This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Approximately 3-5 days prior to BCMA-GPRC5D CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Shanghai Liquan Hospital
Shanghai, China
RECRUITINGDose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-GPRC5D CAR-T infusion.
Time frame: 30 days
Adverse events (AEs)
Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-GPRC5D CAR-T infusion
Time frame: 30 days
Overall remission rate (ORR)
The assessment of ORR by dose group at 90 Days after BCMA-GPRC5D CAR-T infusion.
Time frame: 90 days
Event Free Survival (EFS)
Evaluate the EFS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame: from enrollment to the end of treatment at 2 years
Duration of Response (DOR)
Evaluate the DOR of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame: from enrollment to the end of treatment at 2 years
Overall Survival (OS)
Evaluate the OS of dual-targeting BCMA-GPRC5D CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame: from enrollment to the end of treatment at 2 years
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