eligibility_summary
Adults 18–70 with SLE (ACR/EULAR). Group 1: active LN class III/IV/V (biopsy ≤6 mo) with proteinuria >1.5 g/d, refractory = no remission after 3–6 mo IS. Group 2: refractory thrombocytopenia to high‑dose steroids±IS, PLT 30–50×10^9/L twice, other causes excluded. Nonpregnant, adequate organ function, lymphocytes >0.4×10^9/L, prednisone ≤10 mg/d ≥1 mo. Exclude severe CNS lupus, CrCl <30/dialysis, active infections, HBV/HCV/HIV/TP+, recent surgery/cancer, cardiac/QTc/MI, live vaccine <6 wk, prior CAR‑T.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Early-phase, single-arm trial in refractory SLE (active lupus nephritis or immune thrombocytopenia) testing CNCT19, an autologous anti‑CD19 CAR‑T cell therapy. After leukapheresis, patients receive lymphodepletion with fludarabine (purine analog, 25–30 mg/m2 x3 days) and cyclophosphamide (alkylating agent, 500 mg/m2 x3 days), then 0.25–0.5×10^8 CAR‑positive viable T cells. Mechanism: gene‑modified T cells recognize CD19 and eliminate B cells/plasmablasts, inducing profound B‑cell aplasia to reduce pathogenic autoantibodies and immune complexes and reset humoral immunity. Targets: CD19+ B‑cell compartment (naive/memory B cells, plasmablasts), impacting BCR signaling, autoantibody production, and complement‑mediated inflammation.