A Regimen Finding Study to Induce Tolerance in de Novo Renal Transplantation

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 18
• Participant gender: All

Summary

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 and non-myeloablative conditioning, for tolerance induction in de novo living donor renal transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ITB-Med LLC
• Treatments: Cyclophosphamide; Mycophenolic Acid; Rituximab; Tacrolimus

Criteria

Key Inclusion Criteria:

• Able to understand the study requirements and provide written informed consent before and study assessment is performed

• Male or female patients ≥ 18 to 60 years of age

• Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

• Women of child-bearing potential

• Subjects with a history of cancer

• Donor-specific Antibody