NCT07090954

A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma

An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	GR1803 injection	Participants will receive GR1803 injection.
DRUG	Anti-CD38 Monoclonal Antibody	Participants will receive anti-CD38 monoclonal antibody.

Timeline

• Start date: 2025-08-31
• Primary completion: 2026-07-31
• Completion: 2030-01-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

2 sites across 1 country: China