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

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.

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