NCT05759793

A Study of CAR-GPRC5D in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

An Exploratory Study of Fully Human Anti-GPRC5D Chimeric Antigen Receptor T Cells (CAR-GPRC5D) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label, dose-escalation study to observe the safety and efficacy of different doses of CAR-GPRC5D in patients with R/R MM or Plasma Cell Leukemia.

Detailed description

Apheresis will be performed to manufacture CAR-GPRC5D CAR-T cells. Bridging therapy is allowed between apheresis and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. Then, subjects will receive a single dose infusion of CAR-GPRC5D at 1.0, 2.0, or 3.0 x 10\^6 CAR-T cells/Kg. Subjects will be followed in the study for a minimum of 2 years after infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after infusion.

Conditions

• Relapsed/Refractory Multiple Myeloma
• Plasma Cell Leukemia

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-09-01
• Completion: 2026-10-01
• First posted: 2023-03-08
• Last updated: 2025-05-20

Locations

1 site across 1 country: China