A Phase I Monotherapy Study Assessing the Safety and Efficacy of GR1803, a BCMA×CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma

Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 76 人开始时间: 2022年5月27日最近更新: 2025年8月5日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
入组人数: 76
试验地点: 1
主要终点: DLT

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•ECOG score 0-
•≥18 years of age.
•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.

排除标准

•Prior treatment with any BCMA-targeted therapy.
•Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
•Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.