NCT06298266

To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma

Clinical Study to Evaluate the Safety, Tolerability and Initial Efficacy of Anti-GPRC5D-CD19-CAR-T in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Guangdong Second Provincial General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma

Detailed description

This study is a single-arm, single-center clinical study of IIT to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of GPRC5D-CD19 CAR T cells in subjects with MM. The safety of GPRC5D-CD19 CAR T was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of GPRC5D-CD19 CAR T treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood and bone marrow were collected before and 24 months after the GPRC5D-CD19 CAR T infusion to detection.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	infusion of GPRC5D-CD19 CAR T injection	Infusion of GPRC5D-CD19 CAR T cells injection by dose of 1.0×10\^6 /kg±20 % CAR-T ，3.0×10\^6 /kg±20%、6.0×10\^6 /kg±20%. Administration method: intravenous infusion. Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2024-03-29
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-03-07
• Last updated: 2024-03-07

Locations

1 site across 1 country: China