This study is an open-label, single-arm, dose-escalation trial primarily designed to evaluate the safety and efficacy of a universal CAR-T cell therapy targeting CD19 in the treatment of patients with RJDM. Additionally, the study aims to characterize its pharmacokinetic and pharmacodynamic properties, explore its role in immune system reconstitution, and assess long-term survival benefits.
(1) Age ≥ 5 years old;
(2) Diagnosis of juvenile dermatomyositis (JDM) according to Bohan and Peter criteria;
Intolerance or inadequate response to glucocorticoids (prednisone 1-2mg/kg/d or equivalent dose of other hormones) and at least two immunosuppressants, with hormone therapy lasting for at least 6 months;
Rapid progression of the disease and/or involvement of organs such as lungs, heart, and gastrointestinal tract;
(1) Previously received CAR-T cell therapy (except for those whose safety risks have been judged as eliminated by the investigator);
(2) Accompanied by primary immunodeficiency disease or severe secondary immunodeficiency disease that has not been corrected;
(3) Accompanied by severe, active, or uncontrolled infectious diseases, including but not limited to active tuberculosis, latent tuberculous infection, active viral hepatitis, etc.;
(4) Known to have active malignant diseases or confirmed malignancies before screening (including hematological malignancies and solid tumors, except for resected and cured cutaneous basal cell carcinoma);