eligibility_summary
Inclusion: age 8–45, T1D ≤18 months, ≥1 autoantibody (GAD65, insulin ≤10 days after start, IA‑2 or ZnT8), C‑peptide >0.15 nmol/L on MMTT, fully vaccinated for COVID‑19. Exclusion: recent investigational drugs, severe mAb allergy, unable to do MMTT, serious infections or recent COVID‑19, abnormal labs, immunosuppressives/glucose‑altering meds, cancer, other autoimmune (except stable thyroid/celiac), major CV disease, live vaccine <30 days, pregnancy/lactation or no contraception, psych/substance issues, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05574335 (terminated): Dose-finding trial of siplizumab (TCD601), a humanized anti-CD2 monoclonal antibody (immunotherapy), given weekly subcutaneously for 12 weeks at 0.08/0.12/0.18/0.22 mg/kg in adults and children with recent-onset T1D. Mechanism: Binds CD2 on T cells and NK cells, blocking CD2–LFA-3 (CD58) costimulatory signaling and inducing lymphocyte depletion, with preferential reduction of CD2high effector/memory T cells, aims to shift T-cell phenotypes toward a more regulatory profile (similar to alefacept) and reduce autoreactive T-cell–mediated β-cell destruction. Targets: CD2+ T cells (CD4+/CD8+ effector/memory), NK cells, CD2/CD58 costimulation pathway, downstream T-cell activation in islet autoimmunity. Objectives: identify a safe, metabolically favorable regimen, assess safety and preservation of residual β-cell function. Status: terminated due to greater-than-anticipated lymphodepletion and sponsor ceasing autoimmune development.