Evaluating Safety and Effectiveness of Sip-Tego Regimen for Kidney and Bone Marrow Transplant in Adults with Kidney Failure

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Sip-Tego regimen for inducing donor-specific immune tolerance in adults with end-stage renal disease who have not been previously sensitized. This early phase 1, open-label study involves 6 adult participants receiving kidney and bone marrow transplants to assess this new approach in transplantation. The study treatment includes a conditioning regimen given over six days before transplantation, involving thymic irradiation, low-dose cyclophosphamide, antibody treatments Siplizumab or ATGAM, rituximab, and tegoprubart, followed by bone marrow cell infusion and kidney transplant surgery performed using standard techniques. Donors undergo kidney removal and bone marrow harvest under general anesthesia. The conditioning drugs are administered on specific days relative to the transplant day day 0. Participants will be monitored for up to 7 years after transplantation to evaluate immune tolerance, immunosuppression minimization, and transplant outcomes. Assessments include blood tests, immune function, kidney graft survival, incidence of rejection, infections, and adverse events. Safety monitoring also includes evaluation for radiation side effects and graft-versus-host disease. Participant involvement includes regular study visits and laboratory tests during treatment and long-term follow-up for health and transplant status.

Tolerance Through Mixed Chimerism (Sip-Tego)