A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy

The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Inclusion Criteria:

• Able to understand the study requirements and provide written informed consent before and study assessment is performed
• Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
• Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF

Exclusion Criteria:

• Pregnant or nursing (lactating) women
• Subjects with a history of TB or latent TB infection
• Subjects with a history of cancer