Kidney Transplant Rejection
Conditions
Keywords
Kidney Transplant, Kidney Failure, Anti-rejection therapy, Living Donor, HLA-matched, Hematopoietic Stem Cells (HSC), CD34+, CD3+, T cells, Cellular Therapy, Immunotherapy, Immunosuppression
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMDR-103
MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
Sponsors
Medeor Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
Recipient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Mixed Chimerism | 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). |
Outcome results
None listed