eligibility_summary
Include: Adults 18–65 with SLE (2019 EULAR/ACR), ≥40 kg, refractory to SOC, on stable therapy (steroids ≤30 mg/d, antimalarial/IS stable ≥8 w, started ≥12 w, biologics off ≥4 w), SLEDAI‑2K ≥10, contraception, consent. Exclude: life‑threatening disease, substance abuse, malignancy (except B‑cell lymphoma), recent/planned major surgery, overlap CTD, HIV/immunodeficiency, HBV/HCV/COVID, active TB/infection, recent CV events/DVT/PE, major liver/renal/hematologic labs, CD20 mAb ≤6 mo, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: IM19 CAR‑T cells (CD19‑directed chimeric antigen receptor T‑cell therapy), an autologous, gene‑modified biological given IV (dose 1×10^6/kg or 1×10^8 cells). Mechanism of action: Patient T cells are engineered to express an anti‑CD19 CAR, upon infusion they recognize and kill CD19+ B cells, inducing B‑cell aplasia, reducing autoreactive B cells/plasmablasts, and lowering pathogenic autoantibodies. Targets: CD19+ B‑cell lineage (naive, memory, plasmablasts), germinal center activity, B‑cell receptor/autoantibody pathways, with downstream reduction of immune complex/complement‑driven inflammation in SLE.