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

An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation

The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation

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 first renal transplant from a non-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)