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A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-08-31
Completion Date
2030-01-31
Last Updated
2025-07-29
Healthy Volunteers
No
Conditions
Interventions
GR1803 injection
Participants will receive GR1803 injection.
Anti-CD38 Monoclonal Antibody
Participants will receive anti-CD38 monoclonal antibody.
Locations (2)
Shanghai Fourth People's Hospital Affiliated with Tongji University
Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China