eligibility_summary
Eligible: adults 18-65 with probable/definite myositis by ACR/EULAR 2017, active severe disease, and inadequate response to prior therapy. Exclude: inability to wash out meds/be eligible for anti-CD19 CAR-T, BMI <=18.5 or >=35, severe muscle damage, inadequate organ function, hypersensitivity to study products, other myopathies, unrelated conditions making CAR-T unsafe. Other protocol criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06665256 evaluates rapcabtagene autoleucel (YTB323) vs investigator’s choice in severe, refractory idiopathic inflammatory myopathies. Drug/intervention: Rapcabtagene autoleucel is an autologous, gene‑modified, anti‑CD19 chimeric antigen receptor T‑cell (CAR‑T) therapy given as a single infusion. Mechanism of action: patient T cells are engineered to express a CAR targeting CD19, enabling cytotoxic elimination of CD19+ B cells/plasmablasts to reduce autoreactive B‑cell pools, autoantibody production, and B‑cell–driven antigen presentation/cytokine signaling. Comparator: active standard therapy per protocol (investigator’s choice). Cells/pathways targeted: CD19+ B‑cell lineage, B‑cell receptor/autoantibody‑mediated immune pathways implicated in muscle and lung (ILD) inflammation in IIM.