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

Kidney Transplant Rejection Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03606746
• Other study ID #: MDR-103-L2K
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: Medeor Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Biological:
• MDR-103
MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medeor Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Mixed Chimerism	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).	At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy