eligibility_summary
Adults 18–65 able to consent, first renal transplant from ABO-compatible, non–HLA-identical but haploidentical living donor. Exclude: women of childbearing potential not using highly effective contraception, history of cancer (except basal cell skin or cervical CIS), anti-HLA donor-specific antibodies.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 adaptive trial in living-donor kidney transplantation testing siplizumab (TCD601), a human anti‑CD2 monoclonal antibody biologic, with non‑myeloablative conditioning and donor bone marrow infusion to induce tolerance. Mechanism: siplizumab binds CD2 on T cells and NK cells, blocking the LFA‑3/CD2 costimulatory pathway and depleting/modulating CD2hi effector‑memory T cells, with relative sparing of regulatory T cells. Donor bone marrow plus conditioning aims to establish mixed hematopoietic chimerism, promoting central/peripheral deletion and anergy of donor‑reactive T cells. Targets: CD4+/CD8+ alloreactive T cells, NK cells, CD2 signaling, and tolerance via chimerism.