Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

NCT ID: NCT03363945

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2024-04-11

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.

Conditions

Kidney Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MDR-101

A single dose will be administered via IV infusion post-kidney transplant.

Group Type: ACTIVE_COMPARATOR

MDR-101

Intervention Type: BIOLOGICAL

Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells

Control Arm

Subjects randomized to this arm will receive the standard anti-rejection medications that would be given to kidney transplant recipients who are outside the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MDR-101

Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 matched with donor

• 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

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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Institute for Regenerative Medicine (CIRM)

OTHER

Sponsor Role: collaborator

Medeor Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenuta Micsa, MD

Role: STUDY_DIRECTOR

Medeor Therapeutics

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

USC

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic Hospital

Jacksonville, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

RWJBarnabas Health

Orange, New Jersey, United States

Upstate University Hospital

Syracuse, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

The Methodist Hospital

Houston, Texas, United States

Intermountain Transplant Center

Murray, Utah, United States

INOVA Fairfax Hospital

Fairfax, Virginia, United States

University of Wisconsin School of Medicine

Madison, Wisconsin, United States

CIUSSS de l'Est- de-l'Île-de-Montréal Installation Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

MDR-101-MLK

Identifier Type: -

Identifier Source: org_study_id