eligibility_summary
Adults 18–56 with SLE (2019 EULAR/ACR), ANA ≥1:80 and/or dsDNA/Sm+, SLEDAI‑2K ≥8 (≥6 excluding low complement/dsDNA), ≥6 months standard therapy and ≥2 months active disease, adequate organ function, contraception for 24 months and negative test, consent. Exclude: malignancy, prior CD19/CAR‑T/gene therapy, recent CNS disease/lupus crisis, severe nephritis/dialysis/high‑dose steroids, severe allergy, uncontrolled infection, other autoimmune disease, pregnancy/lactation, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06373991 (Phase 1, single-arm) in moderate–severe SLE. Interventions and mechanisms: • ATHENA CAR-T (ET-901): autologous chimeric antigen receptor T-cell therapy (biologic/cell therapy). Mechanism: engineered T cells recognize a B‑lineage surface antigen (target not specified in record) and kill antigen-positive cells via T‑cell cytotoxicity, aiming to deplete autoreactive B-lineage cells and reduce autoantibody production. • Fludarabine (antimetabolite, purine analog) and Cyclophosphamide (alkylating agent): lymphodepleting chemotherapy to enhance CAR‑T engraftment/expansion. Cells/pathways targeted: B-lineage cells driving humoral autoimmunity (autoreactive B cells/plasmablasts), thereby modulating autoantibody-mediated SLE pathways. Safety and preliminary efficacy assessed up to 24 months.