eligibility_summary
Adults 18–65, ECOG ≤2, ≥12‑wk survival, suitable for apheresis, adequate blood counts/organ function (EF ≥45%, O2 >92%), negative pregnancy test, contraception. Exclude active CNS disease/infections, HBV/HCV/syphilis/HIV, recent live/immune/cytotoxic/growth‑factor drugs, major cardiac/VTE history, other cancers, pregnancy, prior CAR‑T. Indications: r/r SLE, Sjögren’s, diffuse SSc‑ILD, inflammatory myopathy, ANCA vasculitis, APS, disease‑specific exclusions apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06420154: Early-phase, single-arm trial of anti‑CD19 CAR‑T cells (autologous, genetically engineered cellular therapy) for relapsed/refractory autoimmune disease (SLE, Sjögren’s, systemic sclerosis with ILD, inflammatory myopathy, ANCA‑vasculitis, antiphospholipid syndrome). Intervention: single IV infusion of anti‑CD19 CAR‑T cells (1×10^5–1×10^6 cells/kg) after lymphodepleting chemotherapy with fludarabine (purine analog) and cyclophosphamide (alkylator). Mechanism: CAR‑T cells recognize CD19 and selectively eliminate CD19+ B lineage cells (naïve, memory, plasmablasts), aiming to reset autoreactive B‑cell pools, reduce autoantibody production (e.g., ANCA, anti‑dsDNA, anti‑Ro/La, aPL), and disrupt germinal center and B–T helper interactions, lymphodepletion enhances CAR‑T expansion/persistence. Targets/pathways: CD19+ B cells, BCR/germinal center responses, BAFF‑dependent B‑cell survival (indirectly), autoantibody‑mediated cascades.