eligibility_summary
Consent required. Eligible: age 6–<35, ≥2 T1D autoantibodies, ADA Stage 2 dysglycemia + high-risk (HbA1c 5.7–<6.5%, Index60 ≥1.4, or DPTRS ≥7.4), weight/BMI/BP in range, CMV/EBV PCR–, up-to-date vaccines (non-live flu ≥2 wks), negative COVID test, not pregnant, near infusion site, otherwise healthy. Exclude: immunodef/cytopenias/low Hb, active infection/TB/HIV/HBV/HCV, uncontrolled thyroid/celiac, immunosuppressants/steroids, malignancy, liver/renal dysfunction, recent live vaccine/glycemic meds, prior teplizumab/ATG/rabbit allergy/heparin reaction, abnormal labs or Stage 3 T1D.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT04291703 (STOP-T1D Low-Dose ATG) tested antithymocyte globulin (ATG, Thymoglobulin), a rabbit-derived polyclonal IgG biologic immunosuppressant, versus placebo to prevent/delay progression from Stage 2 to Stage 3 type 1 diabetes. Mechanism: ATG depletes and functionally modulates T lymphocytes via complement-dependent cytotoxicity, apoptosis, and Fc-mediated clearance, it preferentially reduces autoreactive effector/memory T cells and may relatively spare or promote regulatory T cells. Target cells/pathways: CD2/CD3/CD4/CD8 T cells, attenuation of TCR signaling, costimulation, and cytokine-driven adaptive immune responses that mediate islet autoimmunity and beta-cell destruction. Comparator: IV normal saline placebo. Phase 2, double-blind, 2:1 randomization. Status: terminated early due to low enrollment.