eligibility_summary
Adults 18–65 with T1D ≥5 yrs (onset <40), on insulin (pump/MDI) and CGM, ≥3 unexplained severe hypos, HbA1c 7.0–9.5%, no C‑peptide, impaired awareness, COVID PCR−. Exclude: prior transplant, BMI>30 or wt≤50, retinopathy, HTN, renal disease, infections (TB/HIV/HBV/HCV/COVID), EBV IgG−, malignancy, thrombo/coagulopathy/anticoag, immunosuppression/biologics, high LFTs, CV/GI disease, pregnancy/breastfeeding, recent live vaccines, prior anti‑CD40L, PRA>20%.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
This Phase 1/2 single‑group trial pairs AT-1501 with cadaveric islet transplantation for brittle T1D. AT-1501 is a humanized IgG1κ anti‑CD40L monoclonal antibody that blocks CD40L–CD40 costimulation, suppressing T‑ and B‑cell activation to prevent islet rejection without calcineurin inhibitors. Concomitant standard agents: anti‑thymocyte globulin (ATG, polyclonal T‑cell–depleting Ab) or basiliximab (anti‑CD25 mAb blocking IL‑2 signaling), mycophenolate mofetil/sodium (antimetabolite, IMPDH inhibitor reducing lymphocyte proliferation), and etanercept (TNF‑α inhibitor fusion protein). Targets/pathways: CD4+ T cells (CD154), APCs/B cells (CD40), IL‑2–driven T‑cell expansion, TNF signaling, and the alloimmune response against transplanted islet beta cells.