eligibility_summary
Adults 18-70 with SLE (ACR 1997), >=6 months duration and active despite >=2 months of stable standard therapy. If on steroids: 7.5-30 mg/day for >=8 weeks, stable >2 weeks. Must be ANA or anti-dsDNA or anti-Sm positive and SELENA-SLEDAI >=8 (>=6 clinical if serology points). Excludes severe nephritis/renal failure or recent high-dose steroids, major lupus crises, non-lupus CNS disease, other systemic autoimmune disease, prior transplant/HSCT, or IgA <10 mg/dL.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Relma-cel (relmacabtagene autoleucel), an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy, tested in dose-escalation (≈25–150×10^6 CAR+ T cells). Mechanism of action: Patient T cells are engineered to express a CAR that binds CD19, upon engagement, they activate and kill CD19-expressing cells, inducing deep B-cell depletion and an immune “reset.” Target cells/pathways: CD19+ B-lineage cells—naive and memory B cells and CD19+ plasmablasts—central to SLE autoimmunity. Pathways affected include B-cell receptor signaling, germinal center activity, and humoral/autoantibody production (e.g., anti-dsDNA), aiming to reduce immune complex–mediated inflammation in SLE.