Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
NCT Number: NCT06503107
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: Nanobody-based biepitope BCMA-targeting CAR-T cells
Sponsor: Wuhan Union Hospital, China
Collaborators: Hebei Taihe Chunyu Biotechnology Co., LTD|Huazhong University of Science and Technology Union Shenzhen Hospital|The Seventh Affiliated Hospital of Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-23
Completion Date: 2026-10-18
Locations: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430022, China

Summary:
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.

Primary Outcome Measures: Incidence 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)., 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., 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)., 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)., 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)., 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)., within 3 years after infusion
Secondary Outcome Measures: 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)., 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)., 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)., within 3 years after infusion
Other Outcome Measures: In vivo expansion and survival of nanobody-based biepitope CAR-T cells targeting BCMA, Quantity of CAR copies in bone marrow, peripheral blood and cerebrospinal fluid will be determined by using flow cytometry and quantitative polymerase chain reaction., within 3 years after infusion