eligibility_summary
Adults 18–60 with active/refractory SLE (ACR 1997 ≥24 wks), ANA ≥1:80 or anti‑dsDNA/anti‑Sm+, on stable therapy ≥30 days, negative pregnancy test, contraception, consent, and compliance. Exclude: severe renal/CNS SLE, major organ dysfunction, active TB, viral hepatitis, HIV, syphilis, or recent infection, recent surgery, cancer, or transplant, recent vaccines/trials, biologics/IVIG/high‑dose steroids/IL‑2/thalidomide/retinoids/TCM, mAb/A‑319 allergy, depression/suicidality, pregnancy/breastfeeding, other safety risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06400537 tests A-319, a biological bispecific antibody (CD19×CD3). Mechanism: A-319 binds CD3 on endogenous T cells and CD19 on B cells, redirecting T‑cell cytotoxicity to deplete pathogenic CD19+ B cells. This is intended to lower autoantibody production, reduce immune complex formation, and dampen systemic inflammation in active/refractory SLE. Design: Phase 1, single-arm, dose-escalation, IV or SC administration over 4 weeks, assessing safety, tolerability, PK/PD, immunogenicity, and preliminary efficacy. Targeted cells/pathways: CD19+ B-cell lineage (naive, memory, plasmablasts), T-cell activation via CD3, and the humoral autoimmunity/immune complex–mediated inflammatory pathway. Location: China. Status: recruiting.