NCT04803006终止2 期
An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- ITB-Med LLC
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome
研究概览
简要总结
The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Able to understand the study requirements and provide written informed consent before any study assessment is performed
- •Male or female patients ≥ 18 to 65 years of age
- •Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor
排除标准
- •Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
- •A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •Recipient with anti-HLA donor-specific antibody (DSA)
研究组 & 干预措施
Arm 1
Experimental
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
干预措施: TCD601 (Biological)
Arm 2
Experimental
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
干预措施: TCD601 (Biological)
结局指标
主要结局
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome
时间窗: 24 months
The proportion of patients off immunosuppression with good safety and tolerability
次要结局
- The incidence of biopsy proven acute rejection, death and graft loss(24 months)
- The incidence of de novo donor-specific antibody(24 months)
研究者
研究点 (3)
Loading locations...
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