eligibility_summary
Eligibility: Diffuse cutaneous SSc per 2013 ACR/EULAR, ≤6 years from first non‑Raynaud symptom, active disease, and up‑to‑date vaccinations per CDC/institution for immunocompromised. Exclude: significant ILD, prior CAR‑T/gene therapy or stem cell transplant, active HBV/HCV, HIV, primary immunodeficiency, splenectomy, major neurologic or cardiac disease, malignancy except treated BCC/SCC, cured in‑situ cervix/breast (≥3y), or other in CR ≥5y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06400303 (KYSA-5) tests KYV-101, an autologous, fully human anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in systemic sclerosis. Type/mechanism: Patient T cells are engineered to express an anti‑CD19 CAR, enabling antigen-specific recognition and cytotoxic elimination of CD19+ B cells, depleting pathogenic B cells and autoantibody-producing plasmablasts in blood, lymphoid, and potentially tissue sites to dampen autoimmune inflammation, fibrosis, and vasculopathy. Participants receive lymphodepletion with cyclophosphamide (alkylating agent causing DNA cross-linking) and fludarabine (purine analog antimetabolite inhibiting DNA synthesis) to reduce lymphocytes and support CAR-T expansion. Targets: CD19+ B-lineage cells, pathways affected include B-cell activation/survival and autoantibody production, with downstream impact on immune-fibrotic signaling in systemic sclerosis.