Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
NCT05739188 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2023-02-23
Summary
It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM).
Conditions
- Multiple Myeloma in Relapse
- Multiple Myeloma, Refractory
Interventions
- BIOLOGICAL
-
Anti-GPRC5D CAR-T cells infusion
This is a"3+3"dose escalation study, in which three dose groups are set three different dose levels of CAR-T cells: Dose level one: 3.0×10\^6 /kg±20%; Dose level two:6.0×10\^6 /kg±20%; Dose level three:1.0×10\^7 /kg±20%.
Sponsors & Collaborators
-
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
lead OTHER
Principal Investigators
-
Sanbin Wang, MD · 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-07
- Primary Completion
- 2025-02-01
- Completion
- 2025-12-31
Countries
- China
Study Locations
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