A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The number and severity of dose-limiting toxicity (DLT) events
研究概览
简要总结
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in With Relapse/Refractory Autoimmune Diseases.
详细描述
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.
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. Age ≥ 18 years old (inclusive), regardless of gender.
- •Adequate hepatic, renal and bone marrow function.3 Participants with relapsed or refractory autoimmune diseases, Including SLE or IM.
排除标准
- •1. Participants with a history of severe drug allergies or allergic constitutions.
- •Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- •Participants with insufficient cardiac function.
- •Participants with congenital immunoglobulin deficiencies.
- •History of malignancy within five years.
研究组 & 干预措施
UCAR T-cell group
Participants will receive the following interventions and dose escalated per protocol: Biological: UCAR-T cells（QT-019C） Drug: Cyclophosphamide
干预措施: UCAR-T cells (Biological)
结局指标
主要结局
The number and severity of dose-limiting toxicity (DLT) events
时间窗: Within 28 Days After QT-019C infusion
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
时间窗: 2 years
The incidence and severity of adverse events (AEs)
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases
时间窗: 2 years
Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
次要结局
- To characterize pharmacodynamics of of UCAR-T cells in participants.(2 years)