eligibility_summary
Eligibility: Adults ≥18 (Spain) or 12–65 (UK) with severe, refractory SLE per 2019 EULAR/ACR and positive ANA (≥1:80), anti‑dsDNA (≥30 IU/mL), or anti‑Smith/histone/chromatin (>ULN). Exclude: recent anti‑CD20, prior anti‑CD19/gene/adoptive T cells, recent live vaccine, neuropsychiatric/drug‑induced/overlap SLE, acute flare, irreversible organ damage, major CNS/CV disease, DVT/PE, serious infection (HBV/HCV/HIV/HTLV/syphilis), cancer <24 mo, transplant, pregnant/lactating, LVEF<45%, SpO2<90%, B‑cell aplasia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: obecabtagene autoleucel (obe-cel, AUTO1), an autologous CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, administered once after lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog). Mechanism of action: CAR-T cells bind CD19 on B cells and kill them, leading to depletion of pathogenic CD19+ B cells/plasmablasts, aiming to reduce autoantibody production and humoral immune activation in severe, refractory SLE. Targets/pathways: CD19-expressing B-cell compartment, downstream reduction of autoantibodies/immune complexes and B cell–driven autoimmune pathways.