This is an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR129. During JWCAR129 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JWCAR129 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JWCAR129 administered intravenously (IV).
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, China
RECRUITINGIncidence of dose-limiting toxicities (DLTs)
Proportion of subjects with adverse events meeting DLT criteria
Time frame: 28 days
Incidence and severity of adverse events
Proportion of subjects with adverse events overall and by severity grade
Time frame: 2 years
Incidence and severity of clinically significant laboratory abnormalities
Proportion of subjects with clinically significant laboratory abnormalities overall and by severity grade
Time frame: 2 years
Cmax
Maximum concentration (Cmax) of JWCAR129 in the blood
Time frame: 2 years
Tmax
Time to maximum concentration (Tmax) of JWCAR129 in the blood
Time frame: 2 years
AUC
Area under the concentration vs time curve (AUC) of JWCAR129 in the blood
Time frame: 2 years
Duration of persistence
Duration of persistence of JWCAR129 CAR T cells in the blood
Time frame: 2 years
Overall response rate
Proportion of subjects with a partial response (PR) or better by IMWG criteria
Time frame: 2 years
CR rate
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Proportion of subjects with a CR by IMWG criteria
Time frame: 2 years