NCT06762119尚未招募1 期
A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects with Autoimmune Diseases
Zhejiang University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 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 autoimmune diseases.
详细描述
This study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of CAR-T Cells to treating Subjects with Autoimmune Diseases.
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 Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia；
- •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
He Huang
Professor
First Affiliated Hospital of Zhejiang University
研究点 (1)
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