This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma . Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in autologous T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. This trial aims to evaluate the safety and anti-tumor efficacy of autologous BCMA-CART in treating relapsed or treatment refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells
Shanghai Bioray Laboratories INC.
Shanghai, Shanghai Municipality, China
Objective response rate (ORR)
Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
Time frame: Up to 90 days after T cell infusion
Incidence and Severity of Adverse Events as a Measure of Safety
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Time frame: Baseline up to 35 days
Duration of persistence of BCMA-CART
BCMA-CART duration be assessed by FACS or QPCR
Time frame: Baseline up to 1 year
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