A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
NCT05998928 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-11-13
Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
Conditions
Interventions
- DRUG
-
Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T Cells
fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 both on three consecutive days during D-7 to D-3 BCMA-GPRC5D CAR-T Cells on day 0
Sponsors & Collaborators
-
Guangzhou Bio-gene Technology Co., Ltd
collaborator INDUSTRY -
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Heng Mei · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-27
- Primary Completion
- 2025-07-27
- Completion
- 2026-07-27
Countries
- China
Study Locations
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