eligibility_summary
Include: ≥18, consent, SLE (2019 ACR/EULAR) with active disease (1 BILAG A or 2 B) post ≥2 therapies plus major organ disease: class III/IV nephritis (UPCR>1, eGFR≥30), cardiac involvement, or lung disease with PFTs ≥60%. CD3+ ≥100/µl, pregnancy ruled out/contraception, COVID‑19 vaccinated/recent infection. Exclude: active CNS SLE, uncontrolled DM, PFTs<60%, recent cancer, cardiac/renal/hepatic failure, HIV/HBV/HCV or active infection, prior transplant, banned meds, hypersensitivity, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: MB-CART19.1, an autologous cellular immunotherapy (biological) of CD4/CD8-enriched T cells engineered with a CD19-directed chimeric antigen receptor (CAR). Mechanism: after lymphodepletion, CAR T cells recognize CD19 and eliminate CD19+ B-lineage cells (naive/memory B cells and plasmablasts), inducing B-cell aplasia, reducing autoantibody production, dampening germinal-center and Tfh–B cell interactions, and aiming to reset humoral autoimmunity in refractory SLE. Targets: CD19+ B cells and downstream humoral immune pathways (autoantibodies, immune complexes). Design: open-label, single-arm Phase I/IIa with dose escalation (0.1–1.0×10^6 cells) then expansion at the recommended dose, assessments include CAR T persistence and B-cell aplasia.