A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients

Key Inclusion Criteria:

• Able to understand the study requirements and provide written informed consent before any study assessment is performed
• Male or female patients ≥ 18 to 65 years of age
• Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

• Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
• A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
• Recipient with anti-HLA donor-specific antibody (DSA)