eligibility_summary
Inclusion: SLE, IIM (DM/IMNM/ASyS/PM), SSc, or RA, autoAb+, active disease: SLE: >=1 major-organ BILAG A, IIM: mod/severe muscle/skin + rash/biopsy/CK>3x ULN or progressive ILD, SSc: dcSSc or progressive ILD, RA: >=3 SJC and >=3 TJC, and inadequate response (SLE/IIM: steroids + >=2 IST, SSc: >=1, RA: >=3). Exclusions: drug-induced SLE, other autoimmune dz, CNS dz, IIM IBM/amyopathic/juvenile, drug-induced/HIV PM, severe damage/cardiac, SSc PAH, severe GI, renal crisis, RA arthritis/deformity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm trial of CC-97540 (BMS-986353), an autologous CD19-targeted Nex-T CAR T-cell therapy, in refractory SLE, idiopathic inflammatory myopathy, systemic sclerosis, and rheumatoid arthritis. Mechanism: engineered T cells recognize CD19 and deplete pathogenic B-cell subsets (naive/memory B cells, plasmablasts) to reduce autoantibodies and reset immune tolerance. Preconditioning uses fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) for lymphodepletion to enhance CAR T expansion. Tocilizumab (anti–IL-6 receptor monoclonal antibody) is available to manage cytokine release syndrome by blocking IL-6 signaling. Targets/pathways: CD19+ B cells, humoral autoimmunity/BCR–autoantibody axis, and IL-6 pathway.