eligibility_summary
Include: 18-75, consent/follow-up, relapsed/refractory autoimmune disease (2022 EULAR/ACR), adequate organ function (coagulation, liver, renal, CBC, LVEF>=45%), negative pregnancy test, contraception >=6 mo. Exclude: allergy, active infection, HBV/HCV/HIV/CMV, malignancy, renal failure/HD or >=100 mg/d steroids, recent CV events/HF/HTN, uncontrolled illness, live vaccine <1 mo, prior transplant or CAR-T/gene therapy, RTX<6 mo, belimumab/telitacicept<30d, JAK<5 t1/2, life expectancy <3 mo, other trial <3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-CAR-DNT cells (RJMty19), a biological/cellular immunotherapy using patient T cells lacking CD4/CD8 (double‑negative T cells) transduced via lentiviral vector to express an anti‑CD19 chimeric antigen receptor. Mechanism of action: CAR binding to CD19 triggers cytotoxic killing of CD19+ B-lineage cells, depleting autoreactive B cells and plasmablasts to reduce autoantibody production, B-cell antigen presentation, and proinflammatory cytokine signaling in SLE, ANCA-associated vasculitis, idiopathic inflammatory myopathies, and systemic sclerosis. Lymphodepletion preconditioning: cyclophosphamide (alkylating agent) and fludarabine (purine analog) to reduce host lymphocytes and support CAR-DNT expansion. Targeted cells/pathways: CD19+ B cells, humoral autoimmunity/autoantibody pathways. Phase: 1, single-arm dose escalation/expansion.