eligibility_summary
Adults 18–75 with 2019 EULAR/ACR SLE, autoantibody+ (ANA ≥1:80 or anti-dsDNA/anti-Sm >ULN), active lupus nephritis without significant chronicity, SLEDAI-2K ≥6 (excluding fever, lupus headache, alopecia, OBS), and inadequate response to ≥2 therapies. Exclude: acute severe flare precluding washout, inadequate organ function, significant ECG/cardiac risks, HIV, HBV/HCV, or grade ≥2 thromboembolism in past 4 weeks. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: rapcabtagene autoleucel, an autologous biological cellular immunotherapy (anti‑CD19 CAR‑T), given once after lymphodepletion. Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B‑lineage cells, CAR engagement triggers T‑cell activation and cytotoxicity, leading to profound depletion of CD19+ B cells/plasmablasts, suppression of autoreactive B‑cell activity, and reduction of autoantibody production. Targets: CD19+ B cells across peripheral blood and lymphoid tissues (including germinal center responses), autoreactive B cells producing anti‑dsDNA/anti‑Sm, with downstream dampening of B‑cell–driven immune pathways implicated in SLE and renal inflammation in lupus nephritis. Study: Phase 2, open‑label, single‑arm in active, refractory SLE/LN.