A Phase 2 Prospective, Multi-center, Open-label Trial to Assess the Safety & Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism & Immune Tolerance in Past Recipients of HLA Zero-mismatch, LD Kidney Transplants
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Persistent Mixed Chimerism
研究概览
简要总结
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
详细描述
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients' immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs.
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective, multicenter clinical trial. MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
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
- •Recipient Inclusion Criteria:
- •Past recipient of a first kidney allograft from an HLA-matched, living related donor
- •Age ≥18 and ≤70 years
- •Single solid organ recipient (kidney only)
- •ABO compatibility with donor
- •Donor Inclusion Criteria:
- •HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
- •Age ≥18 and ≤70 years
- •Past living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
排除标准
- •Recipient Exclusion Criteria:
- •Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
- •Baseline positive donor-specific anti-HLA antibody testing
- •Is taking immunosuppressive therapy
- •Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
- •Donor Exclusion Criteria:
- •History of autoimmune disorders
- •History of type 1 or type 2 diabetes mellitus
- •Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
- •History of infection with Zika virus
结局指标
主要结局
Persistent Mixed Chimerism
时间窗: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy
The primary efficacy endpoint is the proportion of subjects achieving persistent mixed chimerism in MDR-103 treated recipients of past HLA zero-mismatch living donor kidney transplants. Persistent Mixed Chimerism - is defined as at least 6 months of persistent WBC mixed chimerism consisting of at least 5% donor cells in whole blood or in at least one WBC lineage (CD3+ T cells, CD33+ myeloid cells, CD19+ B cells, and/or CD56+ NK cells).
次要结局
未报告次要终点