eligibility_summary
Inclusion: adults ≥18 with adequate marrow, liver, renal, and coagulation function. Disease-specific: RA (2010) active despite stable csDMARDs, SLE (2019) active (BILAG A≥1/B≥2, SLEDAI ≥8, autoantibody+), pSS (2002/2016) platelets <30×10^9/L, SSc (2013) ANA+, HRCT progression. Exclude: major CNS/cardiac disease, transplant, recent vaccines/B‑cell therapy, malignancy, ESRD, infection (incl. TB) or HBV/HCV/HIV/syphilis/CMV/EBV+, severe drug allergy, pregnancy/breastfeeding/planning.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06503224: Open-label, single-center, dose-escalation study (up to 18 adults) of SCAR02, a fourth-generation autologous CAR-T cell therapy co-targeting BCMA and CD19 for refractory autoimmune diseases (RA, SLE, Sjögren’s, systemic sclerosis). Intervention: single IV infusion of anti-BCMA/CD19 CAR-T cells (0.5–3×10^6 cells/kg) following lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog). Mechanism: gene-modified T cells expressing CARs recognize CD19 on B cells and BCMA on plasmablasts/plasma cells, activating T-cell cytotoxicity to deplete B-lineage cells, aiming to reduce autoreactive B cells and autoantibody-producing plasma cells. Targets/pathways: B cells (CD19), plasma cells (BCMA), humoral/autoantibody pathways.