eligibility_summary
Adults 18–70 with SLE (SLICC 2012 or EULAR/ACR 2019), on glucocorticoids + IS/biologic ≥3 mo with stable dose ≥2 wks and active disease, ANA and/or anti-dsDNA/anti-Sm+, SLEDAI-2K ≥7, BILAG A ≥1 organ or B ≥2, PGA >1. Exclude: severe LN, CNS disease, or lupus crisis ≤8 wks, other CNS/autoimmune/vasculitis/inflammatory arthritis/skin dz, B‑cell agents ≤8 wks, RRT ≤3 mo/expected, major surgery ≤4 wks pre‑apheresis/planned tumor resection, SYS6020 allergy, active infection ≤2 wks pre‑apheresis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SYS6020, an autologous BCMA-directed CAR-T cell therapy (gene‑modified cellular immunotherapy) given by IV infusion. Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor targeting BCMA (TNFRSF17). On binding BCMA, CAR-T cells become activated and kill BCMA+ cells, depleting autoreactive antibody-secreting plasma cells and lowering pathogenic autoantibodies. Target cells/pathways: BCMA-expressing long‑lived plasma cells/late B cells, the BAFF/APRIL–BCMA survival axis, downstream B cell–driven autoimmunity in SLE. Phase 1, single-arm safety/dose-finding.