eligibility_summary
Eligible: refractory autoimmune disease per standard criteria: SLE (3-65) incl LN, ITP, TMA, myelitis, PAH, PLE, primary Sjogrens with ITP/myelitis/PAH, systemic sclerosis with ILD/skin sclerosis or PAH, APS with microangiopathy or ITP, refractory IIM, GPA/MPA AAV. Active despite steroids +/- immunosuppressants, stable meds, contraception (neg pregnancy test), ECOG 0-2. Exclude: CNS hypertension, major cardiac/resp disease, malignancy, DIC, serious infection, uncontrolled diabetes, transplant, eGFR<30, inability to stop immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Single-dose autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy following lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog). Type: Gene-modified living cell therapy (CAR-T). Mechanism of action: Patient T cells are engineered to express a CAR recognizing CD19, enabling targeted cytotoxic depletion of CD19+ B-cell subsets (naïve, memory, plasmablasts). This reduces autoantibody production and B cell–mediated antigen presentation, aiming to reset dysregulated humoral immunity. Cells/pathways targeted: CD19-expressing B cells, B-cell receptor/germinal center pathways and downstream autoantibody-driven processes (e.g., ANA, anti-SSA/SSB, ANCA, aPL). Indications include refractory SLE (and variants), Sjögren’s, systemic sclerosis (skin/ILD/PAH), antiphospholipid syndrome, idiopathic inflammatory myopathy, and ANCA-associated vasculitis.