NCT07248176招募中不适用
A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma
Bioray Laboratories1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.
详细描述
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .
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
- •Expected survival of at least 3 months;
- •Subjects should have measurable disease that meets the IMWG 2016 criteria;
- •Previously received at least two lines of prior anti-myeloma therapy ；
- •Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
- •BCMA positive；
- •ECOG score 0-1；
- •No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.
排除标准
- •Pregnant or breastfeeding women;
- •History of other malignant tumors;
- •Active autoimmune diseases requiring immunotherapy;
- •Previously received allogeneic stem cell transplantation;
- •Previous use of CAR-T cells or other genetically modified T cell therapies;
- •Previously received targeted BCMA therapy;
- •Severe cardiovascular disease;
- •Active infection;
- •Positive virology test;
- •Clinically significant central nervous system (CNS) diseases or pathological changes.
研究组 & 干预措施
Treatment group
Experimental
5.0-10×10^6cells/kg
干预措施: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection (Drug)
结局指标
主要结局
DLT
时间窗: Within 28 Days After BRL-305 Infusion
The number and severity of dose-limiting toxicity (DLT) events
AEs
时间窗: Up to 24 Months After BRL-305 Infusion
The total number, incidence, and severity of AEs
次要结局
未报告次要终点
研究者
研究点 (1)
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