eligibility_summary
Include: 18–70, ≥40 kg, ACR 1997 SLE ≥24 wks, active (SELENA‑SLEDAI ≥6, PGA ≥1), on standard therapy ≥8 wks, negative pregnancy test (females), contraception required. Exclude: severe/active lupus nephritis, CNS SLE or crises, hypersensitivity, transplant, systemic autoimmune disease, serious infections (HBV/HCV/HIV/CMV/EBV/syphilis/TB), organ/lab dysfunction, suicidality or severe mental illness, recent live vaccine/surgery/blood products, JAK/BTK/B‑cell/biologics/CAR‑T/steroids/IVIG/plasmapheresis, pregnancy, substance abuse, malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06106906: Single-arm Phase 1/2 trial in active systemic lupus erythematosus testing CD19 CAR-T cell infusion (autologous, genetically engineered cellular immunotherapy). Mechanism: patient T cells are modified to express a chimeric antigen receptor that recognizes CD19, leading to targeted cytotoxic elimination of CD19+ B cells and a B-cell “reset.” This is expected to reduce autoreactive B cells/plasmablasts, autoantibody production, antigen presentation, and pro-inflammatory cytokine output, dampening BCR-driven humoral autoimmunity. Targets: CD19+ B-lineage cells (naive, memory, plasmablasts) and downstream B-cell pathways. Outcomes: safety, efficacy, PK/PD.