Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants

Inclusion Criteria:

Recipient Inclusion Criteria:

1. Planned recipient of a first kidney allograft from an human leukocyte antigen (HLA)-matched, living related donor. Zero-mismatch transplants are excluded
2. Age ≥18 and ≤65 years
3. Single solid organ recipient (kidney only)
4. ABO compatibility with donor

Donor Inclusion Criteria:

1. Human leukocyte antigen (HLA)-mismatched first degree (parent, child or sibling) or second-degree (child of a sibling) relative of the prospective recipient participant. Zero-mismatch transplants are excluded
2. Age ≥18 and ≤65 years
3. Prepared to be a living related kidney donor, and capable of undergoing granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis of hematopoietic cells

Exclusion Criteria:

Recipient Exclusion Criteria:

1. Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
2. Baseline positive donor-specific anti-HLA antibody testing
3. Is taking immunosuppressive therapy
4. Prior hematopoietic cell transplant, organ transplant, any cell therapy, or any gene therapy
5. Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Exclusion Criteria:

1. History of autoimmune disorders
2. History of type 1 or type 2 diabetes mellitus
3. Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
4. History of infection with Zika virus