eligibility_summary
Eligible: dcSSc per 2013 ACR/EULAR, onset within 7 years, with severe/progressive disease (SSc‑ILD, skin, or cardiac involvement). Exclude: inability to complete med washout or tolerate lymphodepletion/CAR‑T, rituximab contraindication or hypersensitivity, other rheumatic disease (incl lcSSc/sine scleroderma, except secondary Sjögren or scleroderma myopathy), pulmonary hypertension, significant renal disease, uncontrolled stage II HTN, live vaccine within 6 weeks. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06655896 (Phase 2, randomized, open-label, assessor-blinded) in severe refractory diffuse cutaneous systemic sclerosis compares: Rapcabtagene autoleucel: autologous anti‑CD19 CAR‑T cell therapy (gene‑modified cellular therapy) given once after lymphodepletion, MOA: engineered T cells recognize and eliminate CD19+ B‑lineage cells (naive/memory B cells, plasmablasts and some plasma cells), aiming to reset humoral autoimmunity and reduce profibrotic signaling. Rituximab: anti‑CD20 monoclonal antibody (biologic mAb) depleting CD20+ B cells via ADCC/CDC, largely sparing long‑lived plasma cells. Target cells/pathways: B‑cell compartment (CD19/CD20), autoantibody production, and downstream immune‑mediated inflammation/fibrosis pathways in dcSSc.