Pilot Study Evaluating the Safety and Efficacy Profile of Regulatory T Cell Therapy in Liver Transplant Recipients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Rate of dose limiting toxicities (DLTs)
研究概览
简要总结
'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell therapy, as adjunct immunosuppressive treatment in the context of liver transplantation
详细描述
Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.
Stage II: To evaluate the efficacy of TR002 administration in allowing for the discontinuation of immunosuppressive therapy in liver transplant recipients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •adult patients with end-stage liver disease listed for primary liver transplant;
- •calculated MELD score ≤ 25 at time of transplantation
排除标准
- •HIV or RNA-positive Hepatitis C Virus infection;
- •autoimmune liver disease
- •previous organ transplant
- •Ebstein Virus and/or Cytomegalovirus sero-negativity
- •chronic use of systemic immunosuppressants
- •hepatocellular carcinoma outside Milano criteria
- •leukocytes <1.5x10^9/L and/or platelets <50x10^9/L.
研究组 & 干预措施
Autologous Regulatory T cell therapy
Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose)
干预措施: Autologous regulatory T cell product (Drug)
结局指标
主要结局
Rate of dose limiting toxicities (DLTs)
时间窗: 1 month after IMP administration
rate of adverse events qualifying as dose limiting toxicities
Graft Loss
时间窗: 24 months
Rate of cellular rejection
次要结局
- Rate of successful immunosuppressive drug withdrawal(24 months)
- Immunosuppressive doses(24 months)
- Prevention of acute and chronic rejection(24 months)
- Acute and Chronic Toxicity(24 months)
- Liver histology(12 months)