eligibility_summary
Recipients: 18–65, 1st/2nd kidney Tx, GFR>60, normal biopsy, no rejection, consent, contraception, COVID−. Donors: DD 18–70 (family consent, adequate CD34+), LD healthy/willing, both with normal labs, viral−, COVID−. Exclusions: ABO-incompatible or DSA>1000, cytopenias, HIV/HBV/HCV+ or other active infection, LVEF<40%, FEV1/DLCO<50%, pregnancy/cancer, high-recurrence renal dz, abnormal LFT/coags, recent trials, drug allergies, substance abuse, uncontrolled NIDDM.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 trial testing delayed tolerance via donor hematopoietic stem cell transplant (HSCT) after kidney transplant to induce mixed chimerism. Interventions and mechanisms: HSCT/bone marrow infusion (cell therapy) to engraft donor HSCs and create central/peripheral tolerance, rituximab (anti-CD20 monoclonal antibody biologic) depletes B cells/plasmablasts to limit donor-specific antibodies, fludarabine (purine analog antimetabolite chemo) lymphodepletes, cyclophosphamide (alkylating chemo) kills proliferating T/B cells, local thymic irradiation (radiotherapy) depletes thymocytes to delete alloreactive clones, siplizumab (anti-CD2 monoclonal antibody biologic) depletes/blocks T and NK cells, short methylprednisolone taper (glucocorticoid). Donors receive G-CSF/TBO-GCSF (cytokine) to mobilize CD34+ HSCs. Targets: CD2+ T cells (including memory), thymocytes, CD20+ B cells, NK/NKT cells, pathways: adaptive alloimmunity, central tolerance. Aim: durable kidney allograft tolerance.