This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.
The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10\^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.
InstituteHBDH
Tianjin, China
Safety: The incidence of treatment-emergent adverse events (TEAEs)
The incidence of treatment-emergent adverse events (TEAEs)
Time frame: 30 days
Overall response rate (ORR)
ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
Time frame: 12 months
Progression free survival (PFS)
PFS(based on IMWG 2016 efficacy evaluation criteria)
Time frame: 6 months、12 months
The CART cell duration in vivo
The copys of BCMA-CART DNA in peripheral blood with qPCR method
Time frame: 12 months
The soluble BCMA changes in peripheral blood
The amount of soluble BCMA in peripheral blood with ELISA method
Time frame: 12 months
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