eligibility_summary
Eligibility: age ≥5, SSc per 2013 ACR/EULAR, ANA/SSc-specific Ab+, mRSS ≥15, refractory to steroids/cyclophosphamide plus other immunomodulators or rapidly progressive, adequate cardiac/renal/hepatic/pulmonary function, negative pregnancy test, contraception, and consent. Exclude: severe PH/major organ disease, prior CAR-T, active CNS/cardiac disease, TB/other infections, recent transplant/GVHD, HBV/HCV/HIV/syphilis, live vaccine <4 wk, pregnancy, malignancy, recent trial, other concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06792344 tests autologous CD19-directed CAR-T cells for refractory childhood-onset systemic sclerosis (Phase 1, single-arm). Intervention: patient T cells are engineered ex vivo with a chimeric antigen receptor targeting CD19 and infused intravenously. Type: cellular gene therapy/immunotherapy (CAR-T). Mechanism: CAR-T cells recognize CD19 and ablate CD19+ B-lineage cells (naive/memory B cells and plasmablasts), producing B-cell depletion/aplasia and an immune “reset,” lowering autoreactive B cells and autoantibody production. Targets: CD19 on B cells, B-cell/autoantibody pathway central to SSc immune dysregulation, with expected downstream effects on inflammatory/fibrotic signaling.