NCT05739188

Safety and Efficacy of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of Relapsed / Refractory(r/r) Multiple Myeloma(MM)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This open label, single-arm, Phase I study aims to evaluate the efficacy and safety of Anti-GPRC5D CAR-T in subjects with relapsed and refractory(r/r) multiple myeloma(MM). A leukapheresis procedure will be performed to manufacture Anti-GPRC5D chimeric antigen receptor (CAR) modified T cells. Prior to Anti-GPRC5D CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.

Conditions

• Multiple Myeloma in Relapse
• Multiple Myeloma, Refractory

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2023-02-07
• Primary completion: 2025-02-01
• Completion: 2025-12-31
• First posted: 2023-02-22
• Last updated: 2023-02-23

Locations

2 sites across 1 country: China