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

NCT03606746 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MDR-103-L2K
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplant Rejection

Keywords

Kidney Transplant; Kidney Failure; Anti-rejection therapy; Living Donor; HLA-matched; Hematopoietic Stem Cells (HSC); CD34+; CD3+; T cells; Cellular Therapy; Immunotherapy; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Investigational Arm

EXPERIMENTAL

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

Interventions

MDR-103 BIOLOGICAL

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

Investigational Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• History of infection with Zika virus

Sponsors & Collaborators

• Medeor Therapeutics, Inc.: lead

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: December 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06