A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
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 in With Relapse/Refractory Autoimmune Diseases.
详细描述
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and 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
- •Age ≥ 18 years old (inclusive), regardless of gender.
- •Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- •Adequate hepatic, renal and bone marrow function.
- •Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.
排除标准
- •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 Drug: Cyclophosphamide Drug: Fludarabine
干预措施: UCAR-T cells (Biological)
UCAR T-cell group
Participants will receive the following interventions and dose escalated per protocol:
Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine
干预措施: Cyclophosphamide (Drug)
UCAR T-cell group
Participants will receive the following interventions and dose escalated per protocol:
Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine
干预措施: Fludarabine (Drug)
结局指标
主要结局
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 the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases(2 years)
- To characterize pharmacodynamics of of UCAR-T cells in participants.(2 years)