eligibility_summary
Inclusion: age 5–<17, JDM meeting ≥4–5 classic criteria, refractory/rapidly progressive JDM or IMNM (SRP/HMGCR) with myositis-specific antibodies, adequate heart/kidney/liver/lung function, suitable for blood collection, negative pregnancy test + contraception, consent. Exclusion: prior CAR‑T, other autoimmune disease, immunodeficiency, serious/active infection, malignancy, major heart disease, chronic steroid need, recent transplant/GVHD, HBV/HCV/HIV/syphilis/CMV, live vaccine <4 wk, pregnancy, recent trial, investigator discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-targeted CAR-T (biological, autologous chimeric antigen receptor T-cell therapy). Patients receive lymphodepleting chemotherapy followed by a single IV infusion of anti-CD19 CAR-T cells. Mechanism of action: Patient T cells are engineered to express a CAR that recognizes CD19, leading to targeted cytotoxic killing of CD19-expressing B-lineage cells. This induces deep B-cell depletion and immune reconstitution, aiming to reduce autoreactive B cells, autoantibody production, and B cell–driven immune activation. Targets (cells/pathways): CD19+ B cells across developmental stages (naive, memory, and plasmablasts). Pathways impacted include humoral autoimmunity (B-cell receptor/autoantibody pathways), B-cell antigen presentation, and related cytokine signaling. Phase: I (dose escalation and expansion) in refractory juvenile dermatomyositis.