Tests GR1803 with an anti-CD38 antibody for relapsed multiple myeloma
Tests GR1803 plus an anti-CD38 antibody in adults with relapsed or hard-to-treat myeloma.
Plain-language title generated from the registry record
Registry title: A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
Key facts
- Where
- Shanghai and Xi’an, ChinaSee the 2 sites
- Phase
- Phase 1/2
Where in China
- Shanghai Fourth People's Hospital Affiliated with Tongji UniversityShanghai, ChinaNo longer taking part
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Trial code
- NCT07090954
- Record updated
- 29 July 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2; Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor; Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.
Exclusion: Prior treatment with any BCMA-targeted therapiy; Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis; Known allergies, hypersensitivity, or intolerance to the study drug or its excipients; Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma; Active infecion.