eligibility_summary
Key eligibility: Adults 18–75 with systemic sclerosis per 2013 ACR/EULAR, early active disease with significant skin, lung, kidney, or heart involvement. Exclude: leukapheresis contraindication, severe reaction to fludarabine/cyclophosphamide, active infection, severe/uncontrolled major organ disease, investigator concern, severe lung/heart impairment, prior CAR T, prior solid organ or hematopoietic cell transplant. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CABA-201, an autologous CD19-directed CAR T-cell therapy, given as a single IV dose after lymphodepleting chemotherapy with fludarabine (purine analog) and cyclophosphamide (alkylating agent). Mechanism: Patient T cells are engineered to express a CAR targeting CD19, causing selective cytotoxic depletion of CD19+ B cells and plasmablasts, aiming to “reset” humoral immunity, reduce autoantibody production, and dampen B cell–driven inflammation, fludarabine/cyclophosphamide facilitate CAR T expansion. Targets: CD19+ B-lineage cells (B cells, plasmablasts), autoantibody-producing pathways, and downstream immune/fibrotic activity in systemic sclerosis.