A Study to Induce Tolerance in de Novo Renal Transplantation

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 12
• Participant gender: All

Summary

The purpose of this study is to evaluate if TCD601with donor bone marrow and conditioning using fludarabine and cyclophosphamide can induce allogeneic tolerance in de novo living donor renal transplant recipients

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

Details

• Lead Sponsor: ITB-Med LLC
• Treatments: Cyclophosphamide; Fludarabine; Sirolimus; 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