This trial aims to evaluate the safety and efficacy of BCMA-UCART 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 T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. BCMA-UCART is a kind of allogeneic CART, originating from T cells of health donors. This open-label, dose-escalation study aims to evaluate the safety and anti-tumor efficacy of BCMA-UCART in treating relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.
Shanghai Tongji Hospital
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 and Tolerability
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Time frame: Up to 35 days after T cell infusion
Duration of persistence of BCMA-UCART
Detect the duration of BCMA-UCART after injection using FACS or Q-PCR
Time frame: Baseline up to 1 year
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