GR1803 injection for patients with relapsed/refractory multiple myeloma
Official title: Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma Complicated by Extramedullary Plasmacytoma
Run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · NCT06952075 · Data updated 2026-11-12
This study is testing if the GR1803 injection can help people with relapsed or refractory multiple myeloma feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | teclistamab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | April 24, 2025 |
| Main results expected | July 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT06952075 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma complicated by extramedullary plasmacytoma and an ECOG performance status of 0-2.
✕Probably not a fit
Patients with prior treatment using BCMA-targeted therapies or those with certain other hematological conditions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of GR1803 injection in patients diagnosed with relapsed or refractory multiple myeloma complicated by extramedullary plasmacytoma. Participants will receive the injection until they experience intolerable toxicity, disease progression, or for a maximum of two years. The study aims to assess how well this treatment works in managing the disease and improving patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have gone: While this approach is relatively novel, similar studies targeting multiple myeloma have shown promising results, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma. Exclusion Criteria: * 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Where it's running
-
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Gang An, PhD
- Email: angang@ihcams.ac.cn
- Phone: +8613502181109
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.