eligibility_summary
Eligible: Russian citizens aged 12–17y5m (males 34–80 kg, females 37–80 kg) with T1D diagnosed <4 months, able to start rituximab ≤122 days from diagnosis, peak stimulated C‑peptide ≥200 pmol/L, and ≥1 T1D autoantibody, participant and guardian consent required. Exclude: other autoimmune disease (except stable thyroid/celiac), active infection/fever, TB/HIV/HBV/HCV, primary immunodeficiency, PI-judged issues, or lack of consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT07041268 tests rituximab plus insulin vs insulin alone in recent-onset adolescent T1D. Drug/intervention: rituximab, a biological chimeric anti-CD20 monoclonal antibody, given in repeated infusion courses, insulin is standard hormone replacement. Mechanism of action: rituximab depletes CD20-expressing B lymphocytes, diminishing antigen presentation and support of autoreactive T cells, it may also target a subset of activated CD20+ T cells. Cells/pathways targeted: CD20+ B cells and CD20+ T cells within the adaptive autoimmune response driving beta-cell destruction in the pancreas, goal is preservation of residual beta-cell function (assessed by C-peptide). Insulin therapy addresses glycemic control but is not disease-modifying.