GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT06566547
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 116
Inclusion Criteria:<br><br> - 1?ECOG score 0-2 2?=18 years of age 3?Multiple myeloma must be measurable by central<br> laboratory assessment: Serum monoclonal paraprotein (M-protein) level =0.5 g/dL or<br> urine M-protein level =200 mg/24 hours; or<br><br>Light chain multiple myeloma without measurable disease in the serum or the urine:<br><br>Serum immunoglobulin free light chain (FLC) =10 mg/dL and abnormal serum immunoglobulin<br>kappa lambda FLC ratio.<br><br>Exclusion Criteria:<br><br> - 1?Prior treatment with any BCMA-targeted therapy 2?Known active CNS involvement or<br> exhibits clinical signs of meningeal involvement of multiple myeloma 3?Known<br> allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its<br> excipients 4?Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome<br> (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin<br> changes), or primary amyloid light-chain amyloidosis.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR evaluated by IRC
- Secondary Outcome Measures
Name Time Method ORR evaluated by investigator;Progression-free survival (PFS) evaluated by IRC;MRD negative rate;AE