Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
- Conditions
- Kidney Transplant Rejection
- Interventions
- Biological: MDR-101
- Registration Number
- NCT03363945
- Lead Sponsor
- Medeor Therapeutics, Inc.
- Brief Summary
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in 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 recipients' immune system to accept a transplanted kidney without the need for long term use of immunosuppression drugs.
The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Planned 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 matched with donor
Recipient
- 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 Inclusion Criteria:
- HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant
- Age ≥18 and ≤70 years
- Prepared to be a living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
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, T. cruzi, or syphilis
- History of infection with Zika virus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MDR-101 MDR-101 A single dose will be administered via IV infusion post-kidney transplant.
- Primary Outcome Measures
Name Time Method Functional immune tolerance defined as Up to 36 months post-kidney transplant * Achievement of the required duration of persistent donor mixed chimerism to permit calcineurin inhibitor immunosuppressive withdrawal beginning at 6-7 months post-kidney transplant surgery, and
* Successful withdrawal from all immunosuppressives by at least 12 months post-kidney transplant surgery, and
* Subsequent successful maintenance off all immunosuppressive drugs for at least 24 additional months (out to at least 36 months post-kidney transplant surgery) without biopsy-proven acute rejection, de novo Donor Specific Antibody, transplant kidney loss, or subject death. Loss to follow-up will be adjudicated as a failure in intent-to-treat analysis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
USC
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic Hospital
🇺🇸Jacksonville, Florida, United States
RWJBarnabas Health
🇺🇸Orange, New Jersey, United States
Upstate University Hospital
🇺🇸Syracuse, New York, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Intermountain Transplant Center
🇺🇸Murray, Utah, United States
University of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
CIUSSS de l'Est- de-l'Île-de-Montréal Installation Hopital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Yale University
🇺🇸New Haven, Connecticut, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States