eligibility_summary
Adults 18–65 with diffuse systemic sclerosis (2013 ACR) that is refractory after ≥6 mo standard therapy or progressive in 6 mo (mRSS +≥3 or FVC −>10% or >5% with DLCO −>15%). No active infection ≤2 wks, leukapheresis access, adequate renal/marrow/liver/coag (CrCl≥50), LVEF≥55. hCG− and contraception. Exclude: NYHA IV, FVC<45%/DLCO<40%, non‑SSc HRCT, prior ASCT/CAR‑T, renal crisis, autoimmune needing systemic Rx, severe allergy, Ig deficiency, malignancy (exceptions), psych disease, recent investigational therapy, pregnancy/lactation, live vaccine ≤1 mo, active TB, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Relmacabtagene autoleucel (Relma-cel), an autologous CD19-directed CAR-T cell therapy (gene-modified cellular immunotherapy). Mechanism: patient T cells are engineered to express an anti-CD19 chimeric antigen receptor, upon binding CD19 they activate, expand, and lyse target cells, driving deep B-cell depletion and an immune “reset,” intended to lower autoreactive B cells, autoantibodies, and inflammatory/profibrotic signaling in systemic sclerosis. Targets: CD19+ B-lineage cells (naive/memory and plasmablasts), B-cell receptor/activation pathways, antigen presentation and autoantibody production, with downstream cytokine-driven immune-fibrotic circuits. Study: single-arm, dose-ranging (25/50/75×10^6 CAR+ T) with lymphodepleting chemotherapy.