Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
intravenous infusion
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGDose limiting toxicities (DLT)
Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration
Time frame: 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 24 months
ORR (overall response rate)
Proportion of subjects with the best overall response (BOR)
Time frame: 3 months,6 months
CRR (complete response rate)
Proportion of subjects with the BOR of sCR+CR at Month 3
Time frame: 3 months
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