To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma,this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
This study is a multicenter, open-label, prospective, single-arm clinical study with patients with relapsed/refractory multiple myeloma as the test subjects, in order to evaluate the safety and efficacy of nanobody-based biepitope CAR-T cells targeting BCMA in the treatment of R/RMM, and to collect CAR-T PK/PD indicators. The structure of BCMA target CAR-T is designed to identify two different epitopes of BCMA protein with two recognition domains, in order to killig MM cells without secreting more pro-inflammatory factors and avoiding escape caused by the limitations of single BCMA antigen recognition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Each patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by intravenous infusion on day 0.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGIncidence of Treatment-related Adverse Events
Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: within 3 years after infusion
Overall response rate (ORR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
Disease overall response rate (ORR) will be assessed from CAR-T cell infusion to death or last follow-up (censored). The rates of stringent complete response (sCRs), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR) will be assessed from CAR T cell infusion to death or last follow-up (censored). ORR will be assessed from CAR T cell infusion to death or last follow-up.
Time frame: within 3 years after infusion
The rates of complete response (CR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
CR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Very good partial response (VGPR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
VGPR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Partial response rate (PR) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
PR will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Stable diseases (SD) of nanobody-based biepitope CAR-T cells targeting BCMA in R/R MM
SD will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Overall survival (OS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
OS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Progression-free survival (PFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
PFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
Event-free survival (EFS) of nanobody-based biepitope CAR-T cells targeting BCMA in Relapsed/Refractory multiple myeloma
EFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).
Time frame: within 3 years after infusion
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