GR1803 injection for patients with relapsed/refractory multiple myeloma
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
PHASE2 · Genrix (Shanghai) Biopharmaceutical Co., Ltd. · NCT06952075
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. (industry) |
| Drugs / interventions | teclistamab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06952075 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with prior treatment using BCMA-targeted therapies or those with certain other hematological conditions will not benefit from this study.
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 performed: While this approach is relatively novel, similar studies targeting multiple myeloma have shown promising results, indicating potential for success.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myleoma