eligibility_summary
Adults 18–80 with RA (2010), ACPA+, DAS28‑ESR>3.2, failed ≥1 csDMARD and ≥2 ts/bDMARDs, US‑active synovitis, agree to synovial biopsy, contraception and negative pregnancy test. Exclude: cytopenias (ANC<1000, ALC<500, Hb<8), severe renal/hepatic/cardiopulm disease, HIV/HBV/HCV/COVID‑19 or untreated TB, prior anti‑CD19/adoptive/gene therapy, prior transplant, csDMARD≠MTX, pregnancy/lactation, cancer <5y, live vaccines, abuse or dependence/institutionalized, other trials <3mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II randomized, open-label trial in ACPA-positive, treatment-refractory RA compares KYV-101 (autologous, fully human anti-CD19 CAR T-cell therapy, single IV dose) vs rituximab (anti-CD20 chimeric monoclonal antibody, 1 g IV on days 0 and 14, optional retreat at week 24). Mechanisms: KYV-101 CAR T cells recognize CD19 on B-lineage cells (pre-B, naïve, memory B cells and plasmablasts) and exert targeted cytotoxicity, driving deep B-cell aplasia and immune “reset,” aiming to reduce ACPA autoantibodies, rituximab binds CD20 on mature B cells, depleting them via ADCC/CDC/apoptosis while generally sparing long-lived plasma cells. Targets/pathways: pathogenic B cells, ACPA autoantibody axis, B-cell receptor–mediated and germinal center responses. Safety management includes tocilizumab for CRS (IL-6 blockade) and dexamethasone for ICANS. Follow-up: 52 weeks.