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A Phase 3 Prospective, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants

Clinical Trial Details

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. 

Key Eligibility: 

Inclusion

  • Planned recipient of a first kidney allograft from an HLA-matched, living related donor.
  • Age greater than or equal to 18 and less than or equal to 65 years at the time of providing informed consent.
  • Single solid organ recipient (kidney only).
  • ABO compatibility with donor
  • Able and willing to fully comply with all study procedures and restrictions.

Exclusion 

  • Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  • History of HUS, atypical HUS, or TTP.
  • Is taking immunosuppressive therapy [eg, glucocorticoids, cyclosporine, mycophenolate, tumor necrosis factor (TNF) inhibitors] for multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, or other acute or chronic condition.
  • Tests confirmed positive for HIV-1/2, human T-cell lymphotropic virus (HTLV)-I/II, West Nile Virus, HBV, HCV ,T. cruzi, or syphilis. Epstein-Barr Virus (EBV)- positive donors will be excluded if the prospective transplant recipient is EBV naïve. 
  • History of infection with Zika virus (ZIKV) in the past 6 months

Study contact by location

Upper East Side - Manhattan

Contact(s)

Melissa Eddie, RN
med9043@nyp.org

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1710018658

ClinicalTrials.gov:

NCT03363945

Status

Open to Enrollment

Age Group

Adult

Sponsor