eligibility_summary
Eligibility: Adults 18–75 with IIM per 2017 EULAR/ACR (DM, ASyS, IMNM), active disease despite SOC (elevated CK, DM rash, or biopsy/MRI/EMG), and muscle weakness. Juveniles 6–17 with IIM per 2017 criteria and active disease despite SOC. Key exclusions: leukapheresis contraindication, severe reaction to fludarabine/cyclophosphamide, active infection, uncontrolled major organ disease, significant lung/cardiac impairment, prior CAR‑T, prior solid organ/HCT transplant. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06154252 tests CABA-201 (Resecabtagene autoleucel, “Rese-cel”), an autologous CD19-directed CAR T-cell therapy, in adults and children with active idiopathic inflammatory myopathies (DM, anti-synthetase syndrome, IMNM, JIIM). Patients receive a single CABA-201 infusion after lymphodepletion with cyclophosphamide (alkylating agent causing DNA crosslinks) and fludarabine (purine analog inhibiting DNA synthesis) to enhance CAR T expansion. Mechanism: engineered T cells recognize CD19 and eliminate CD19+ B cells, depleting autoreactive B cells and plasmablasts, thereby reducing autoantibody production and B cell–driven inflammation. Target cells/pathways: CD19+ B-cell compartment (naive, memory, plasmablasts) and the humoral autoimmunity/BCR-driven axis.