This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT053 CAR-BCMA T in patients with relapsed and/or refractory multiple myeloma.
The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to Detailed Description: verify the efficacy and safety of the dose proposed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Phase 1, Safety and tolerability: dose limiting toxicity
dose limiting toxicity
Time frame: 28days post administration of CAR-T-cells
Phase 2, efficacy of CT053 CAR-BCMA T cells: overall response rate
overall response rate (ORR)=(sCR+CR+VGPR+PR)
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
Minimal residual disease (MRD) negativity
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
TTR TIme to Response
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
Complete Response (CR) /stringent Complete Response (sCR)
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
≥Very Good Partial Response (VGPR), including VGPR, CR, sCR
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
ORR at Wk12
Time frame: 3 months post administration of CAR-T-cells
Additional efficacy evaluation after 12 weeks of CT053 CAR-BCMA T cells infusion
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Beijing Chaoyang hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China
The 2nd People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
...and 13 more locations
CBR, clinical benefit rate
Time frame: 3 months post administration of CAR-T-cells
Safety and tolerability of CAR-BCMA T cell therapy
AE\&SAE
Time frame: through 24 months post administration of CAR-T-cells
Pharmacokinetics (the cell persistence duration in peripheral blood)
Copy numbers of CAR-BCMA gene in peripheral blood
Time frame: through 24 months post administration of CAR-T-cells
Pharmacokinetics (the cell persistence duration in peripheral blood)
Number of CAR positive cells in peripheral blood
Time frame: through 24 months post administration of CAR-T-cells
Safety and tolerability of CAR-BCMA T cell therapy
positivity of ADA (Anti-CAR-T antibody)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Overal response rate (ORR)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Complete Response (CR) /stringent Complete Response (sCR)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
≥Very Good Partial Response (VGPR), including VGPR, CR, sCR
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Duration of Response (DOR)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Clinical Benefit Rate (CBR)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Time to Response (TTR)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Minimal residual disease (MRD) negativity
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Progression Free Survival (PFS)
Time frame: through 24 months post administration of CAR-T-cells
Efficacy endpoint of CAR-BCMA T cells after infusion
Overall Survival (OS)
Time frame: through 24 months post administration of CAR-T-cells