eligibility_summary
Inclusion: Adults ≥18 with refractory RA (2010 ACR/EULAR): failed csDMARDs + ≥2 b/tsDMARDs, active disease or steroid-dependent or ≥3 swollen/tender joints, on stable csDMARDs, TB-free, adequate organ function, LVEF ≥45%, contraception 12 mo post SWK002. Exclusion: malignancy, CNS disease, allo-HSCT, chemo/trials/cytotoxic/immunosuppressants, HBV/HCV/HIV/syphilis, active infection, major blood loss/transfusion, pregnancy/lactation, other systemic inflammatory disease, unstable angina/MI, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SWK002, an autologous anti‑CD19 CAR‑T cell therapy (cellular gene therapy). Patients receive lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog) to enhance CAR‑T expansion, followed by split IV infusion of 1–6×10^6 CAR‑T cells/kg. Mechanism of action: Engineered T cells express a CAR that recognizes CD19, inducing cytotoxic depletion of CD19+ B‑lineage cells (naïve and memory B cells, plasmablasts). This reduces autoantibody production, antigen presentation, and B–T cell co‑stimulation, dampening downstream inflammatory cytokine networks and aiming to “reset” the B‑cell compartment. Targets: CD19+ B cells, humoral autoimmunity pathways including germinal center activity, autoantibody generation, and B–T cell interactions. Study: Open‑label, single‑site, dose‑escalation in difficult‑to‑treat RA. Status: Recruiting.