A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
NCT05219721 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-06-11
Summary
This study is a single-center, open-label, dose-exploration study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or plasma cell leukemia.
Conditions
- Relapsed/Refractory Multiple Myeloma
- Plasma Cell Leukemia
Interventions
- DRUG
-
CAR-T (CAR-GPRC5D)
CAR-GPRC5D (RD118) is an individualized, gene-modified autologous T-cell immunotherapy product targeting GPRC5D that identifies and eliminates malignant and normal cells expressing GPRC5D. The CAR structure comprises a fully human single-domain antibody fragment (VHH) targeting GPRC5D, fused with intracellular co-stimulatory (4-1BB) and activation (CD3ζ) signaling domains.
Sponsors & Collaborators
-
Nanjing IASO Biotechnology Co., Ltd.
collaborator INDUSTRY -
Chunrui Li
lead OTHER
Principal Investigators
-
Chunrui Li · Tongji Hospital
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
- 2022-03-17
- Primary Completion
- 2025-09-01
- Completion
- 2025-10-01
Countries
- China
Study Locations
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