eligibility_summary
Include: age 8–45, T1D ≤100 days, ≥1 islet autoantibody, MMTT C‑peptide ≥0.2 pmol/mL ≥21 days post‑dx, weight ≥20 kg, agree to intensive care, CGM, vaccine rules, and contraception. Exclude: abnormal labs, immune deficiency or immunosuppression, active/chronic infection (TB, recent mono, HIV/HBV/HCV), pregnancy/lactation, glycemia‑altering meds, significant thyroid disease, malignancy, or prior T1D trial agents.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT03929601: Sequential immunotherapy in new-onset type 1 diabetes. Interventions: 1) Rituximab-pvvr (Ruxience), a chimeric anti-CD20 monoclonal antibody (IV, 4 weekly doses). Mechanism: binds CD20 on pre-B and mature B cells, inducing B-cell depletion via complement and ADCC, reduces autoreactive B cells, antigen presentation, and autoantibody production. 2) Abatacept (Orencia), a CTLA-4–Ig fusion protein (SC weekly for 20 months) vs placebo. Mechanism: binds CD80/CD86 (B7) on antigen-presenting cells, blocking CD28-mediated T-cell co-stimulation, suppresses activation of autoreactive T cells. Targets/pathways: B cells (CD20), APC B7 (CD80/86)–T-cell CD28 co-stimulation axis, downstream autoreactive CD4/CD8 responses driving β-cell destruction. Goal: preserve endogenous insulin (C-peptide).