NCT07102706CompletedPhase 1/2
Phase I Trial of GR1803 Injection in Patients With RRMM
A Phase I Monotherapy Study Assessing the Safety and Efficacy of GR1803, a BCMA×CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 30 Jul 2025
- Start date
- 27 May 2022
- Primary completion date
- 20 May 2025
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT07102706
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 76
- From 27 May 2022 to the primary completion date, 20 May 2025
- 1 site 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 therapy.
Other illness
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Other
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Who the study is looking for
- ECOG score 0-2.
- ≥18 years of age.
- Multiple myeloma must be measurable by central laboratory assessment:
- Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
- Light chain multiple myeloma without measurable disease in the serum or the urine:
- Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.