Status:
RECRUITING
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06566547
Start Date
August 26 2024
End Date
August 1 2027
Last Update
April 27 2025
Active Locations (1)
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1
he First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003