NCT07090954Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 31 Aug 2025
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT07090954
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 32
- From 31 Aug 2025 to the primary completion date, 31 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any BCMA-targeted therapiy.
Other illness
- 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.
Other
- Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Active infecion.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Fourth People's Hospital Affiliated with Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.