NCT04803058终止2 期
A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, 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
- 7
- 试验地点
- 6
- 主要终点
- The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
研究概览
简要总结
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal 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 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 renal transplant from a non-human leukocyte antigen (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)
结局指标
主要结局
The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
时间窗: 24 months
The proportion of patients off immunosuppression with good safety and tolerability
次要结局
- The incidence of DSA(24 months)
- Incidence of biopsy proven acute rejection, death, and graft loss(24 months)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
1 期
Using T-Cell Alloreactivity and Chimerism to Guide Immunosuppression Minimization in Intestinal TransplantationIntestinal TransplantationNCT04804891Columbia University6
Unknown
1 期
CD19-redirected Autologous Cells (CAR-CD19 T Cells)CD19 Positive Malignant B-cell Leukemia and LymphomaNCT02933775RenJi Hospital45
招募中
早期 1 期
TCR-T Cells in the Treatment of Advanced Pancreatic CancerPancreatic CancerNCT06054984Ruijin Hospital18
暂停
1 期
Evaluation of Safety and Efficacy of T1h (anti-CD6) as Monotherapy and in Combination with Methotrexate in Patientes with Rheumatoid ArthritisArthritis, RheumatoidArthritisRheumatic DiseasesJoint DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesAutoimmune DiseasesAutoimmune System DiseasesRheumatoid ArthritisRPCEC00000035Center of Molecular Immunology (CIM)
招募中
1 期
Administration of Anti-siglec-6 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)Acute Myeloid Leukemia RefractoryAcute Myeloid Leukemia, in RelapseNCT05488132Xuzhou Medical University20