NCT06900764尚未招募不适用
A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年10月10日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between 18 and 65 years old;
- •Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- •Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
- •SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
- •Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
- •Good organ functions;
- •Voluntary participates this trial and can comprehend and sign ICF.
排除标准
- •Had or has active malignancy;
- •Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- •Combined with other autoimmune disease that needs treatment;
- •Pregnant or lactating women;
- •Has other factors that deemed not suitable by investigator.
研究组 & 干预措施
CAR-T treatment
Experimental
干预措施: CAR-T cell (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 0~28 day after treatment
Frequency of AEs, SAEs
时间窗: 0 day to 24 months after treatment
次要结局
未报告次要终点
研究者
Qiubai Li
Director of the Department of Rheumatology and Immunology
Wuhan Union Hospital, China
研究点 (1)
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