Summary

for people ages 18-70 (full criteria)
at Stanford, California and other locations
study started
estimated completion
Flavio Vincenti

Description

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.

Official Title

A Phase 3, 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

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.

Keywords

Kidney Transplant Rejection kidney transplant cellular therapy anti-rejection therapy living donor HLA-matched hematopoietic stem cells (HSC) CD34+ CD3+ T cells MDR-101

Eligibility

For people ages 18-70

Recipient Inclusion Criteria:

  • 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 compatibility with donor

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 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

Locations

  • Stanford University Medical Center accepting new patients
    Stanford California 94305 United States
  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist

  • Flavio Vincenti
    Professor, Medicine. Authored (or co-authored) 255 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medeor Therapeutics, Inc.
ID
NCT03363945
Phase
Phase 3
Study Type
Interventional
Last Updated