This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Single infusion of PD1-BCMA-CART administered intravenously (i.v.)
First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, 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 v5.0 criteria
Time frame: Up to 35 days after T cell infusion
Duration of persistence of PD1-BCMA-CART
Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR
Time frame: Baseline up to 2 year
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