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Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606746
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Medeor Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Rejection Biological: MDR-103 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Prospective, Multi-center, Open-label Trial to Assess the Safety & Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism & Immune Tolerance in Past Recipients of HLA Zero-mismatch, LD Kidney Transplants
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational Arm
A low-dose Total Lymphoid Irradiation (TLI) and anti-thymocyte globulin (ATG) combined with a single IV infusion of MDR-103 and standard anti-rejection medications in past recipients of HLA Zero-mismatch living donor kidney transplants.
 Biological: MDR-103
MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells


Outcome Measures
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Primary Outcome Measures :
  1. Persistent Mixed Chimerism [ Time Frame: 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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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
  • History of infection with Zika virus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606746


Contacts
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Contact: Lenuta Micsa, MD 646-239-9748 lmicsa@medeortx.com

Sponsors and Collaborators
Medeor Therapeutics, Inc.
More Information
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Responsible Party: Medeor Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03606746    
Other Study ID Numbers: MDR-103-L2K
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medeor Therapeutics, Inc.:
Kidney Transplant
Kidney Failure
Anti-rejection therapy
Living Donor
HLA-matched
Hematopoietic Stem Cells (HSC)
 CD34+
CD3+
T cells
Cellular Therapy
Immunotherapy
Immunosuppression