GR1803 Injection in Patients With RRMM
- Registration Number
- NCT06952075
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Brief Summary
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 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GR1803 GR1803 -
- Primary Outcome Measures
Name Time Method ORR 2 years Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) 2 years Time from enrollment to tumor progression or death from any cause
AE 2 years adverse event
Trial Locations
- Locations (1)
Institute of Hematology & Blood Diseases Hospital
🇨🇳Tianjin, Tianjin, China