Cellular Immunotherapy in Recipients of HLA-matched, 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 recipients'
immune system to accept a transplanted kidney without the need for long term use of
immunosuppression drugs.

The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101
for the induction of transplant immune tolerance in a prospective, randomized, multicenter
clinical trial. MDR-101 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.

Recipient Inclusion Criteria:

- Planned recipient of a first kidney allograft from an HLA-matched, living related
donor

- Age ≥18 and ≤65 years

- Single solid organ recipient (kidney only)

- ABO compatibility with donor

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 Inclusion Criteria:

- HLA-matched first degree (parent, child or sibling) or second-degree (child of a
sibling) relative of the prospective recipient participant

- Age ≥18 and ≤65 years

- Prepared to be a living related kidney donor, and capable of undergoing G-CSF
mobilization and apheresis of hematopoietic cells

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