A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- ITB-Med LLC
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Liver Transplant Recipients off of immunosuppression Therapy.
研究概览
简要总结
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance 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
- Prevention
- 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 understand the study requirements and provide written informed consent before and study assessment is performed
- •Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
- •Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF
排除标准
- •Pregnant or nursing (lactating) women
- •Subjects with a history of TB or latent TB infection
- •Subjects with a history of cancer
研究组 & 干预措施
Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
干预措施: TCD601 (Biological)
Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
干预措施: Cyclophosphamide (Biological)
Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
干预措施: TAC (Drug)
Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
干预措施: MMF (Drug)
Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Number of Liver Transplant Recipients off of immunosuppression Therapy.
时间窗: 30 months
Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients
次要结局
- The Incidence of adverse events and serious adverse events(30 months)