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临床试验/NCT06952075
NCT06952075招募中2 期

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 Complicated by Extramedullary Plasmacytoma

Genrix (Shanghai) Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
30
试验地点
1
主要终点
ORR

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 2 years 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
Na
干预模型
Single Group
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

  • •1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be Complicated by Extramedullary Plasmacytoma.

排除标准

  • •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.

研究组 & 干预措施

GR1803

Experimental

干预措施: GR1803 (Drug)

结局指标

主要结局

ORR

时间窗: 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)

次要结局

  • Progression-free survival (PFS)(2 years)
  • AE(2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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