Clinical trial NCT03606746: Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
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
Lead sponsor: Medeor Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Persistent Mixed Chimerism
timeFrame: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: