eligibility_summary
Adults 18–70 with moderate–severe active autoimmune disease not in CR post standard tx, ECOG ≤2, LVEF ≥45%, survival >12 wks, adequate renal/hepatic function, oral corticosteroids+immunosuppressive/biologic ≥2 wks. Exclude severe allergy to study meds, marrow-failure syndromes, active/uncontrolled infection, NYHA III/IV HF, CNS disease, active malignancy, bleeding risk, recent systemic steroids, MI/unstable angina/CHF, pregnant/lactating/planning pregnancy, recent trial, or PI judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early Phase 1, single-arm study in relapsed/refractory B‑cell–mediated autoimmune diseases. Interventions and mechanisms: • KN5501 anti‑CD19 CAR NK cells—genetically engineered natural killer cell therapy. The CAR targets CD19 on B cells, triggering NK cytotoxicity (perforin/granzyme) to deplete pathogenic CD19+ B cells/plasmablasts and lower autoantibody production, persistence/expansion assessed. • Lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to reduce host lymphocytes and improve CAR‑NK engraftment/expansion. Targets/pathways: CD19+ B cells, impacting B‑cell receptor/humoral immune pathways via B‑cell depletion. Primary focus: safety/feasibility, secondary: efficacy.