eligibility_summary
Include: 18–90, active SLE (EULAR/ACR ≥10, SELENA‑SLEDAI ≥8), CD19+, meets minimum blood counts and organ function (incl LVEF ≥50%), venous access, negative pregnancy test + contraception, consent. Exclude: severe LN (SCr >2.5)/dialysis, CNS/psychiatric disease, serious organ disease, immunodeficiency, uncontrolled infection (HIV/HBV/HCV/syphilis) or vax <4 wks, recent IS, Cy/Flu contraindication, recent surgery, pregnancy/plans, prior CD19/BCMA, trial <3 mo, most cancers (few exceptions).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06350110 tests BH002, a fourth‑generation dual‑target autologous CAR‑T therapy (CD19/BCMA, EB‑BH2024‑2) for refractory SLE. Patients receive lymphodepleting fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylator) followed by IV CD19/BCMA CAR‑T cells, with optional repeat doses. Mechanism: gene‑modified T cells recognize CD19 on B cells and BCMA (TNFRSF17) on plasmablasts/plasma cells, inducing cytolytic depletion of autoreactive B‑lineage cells, lowering autoantibody production and immune complex formation, and potentially resetting immune homeostasis. Targets: CD19+ B cells, BCMA+ plasma cells, B‑cell/autoantibody‑driven inflammatory pathways.