GR1803 injection for patients with relapsed or 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
This study is testing a new injection called GR1803 to see if it can help people with relapsed or refractory multiple myeloma feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genrix (Shanghai) Biopharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | teclistamab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06566547 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of GR1803 injection in patients suffering from relapsed or refractory multiple myeloma. Participants will receive the injection until they experience intolerable side effects, disease progression, or for a maximum of two years. The study aims to assess the drug's impact on measurable disease markers, such as serum monoclonal paraprotein levels. The trial is designed to provide insights into the potential benefits of GR1803 for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with measurable multiple myeloma and an ECOG performance status of 0-2.
Not a fit: Patients with prior treatment using BCMA-targeted therapies or those with certain severe forms of multiple myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: While this approach is focused on a specific treatment, 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 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. 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
Hangzhou, Zhejiang
- he First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jie Jin, PhD — First Affiliated Hospital of Zhejiang University
- Study coordinator: Jie Jin, PhD
- Email: jiej0503@zju.edu.cn
- Phone: 86-571-87236702
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.