In Vivo CAR-T for Refractory Graves' Disease

Exclusion Criteria

• •History of severe drug allergy or known allergic predisposition.
• •Presence or suspected presence of uncontrolled active infection.
• •History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation.
• •Presence of significant heart disease, such as angina, myocardial infarction, heart failure, or clinically significant arrhythmias.
• •Receipt of any mRNA-LNP product or other lipid nanoparticle (LNP)-based therapy within the past 2 years.
• •Receipt of a live vaccine within 30 days prior to screening.
• •History of malignant tumors.
• •Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA above the detection limit; positive hepatitis C virus (HCV) antibody with detectable HCV RNA; positive human immunodeficiency virus (HIV) antibody; or positive syphilis test.
• •Presence of psychiatric disorders or severe cognitive impairment.
• •Hematologic dysfuction at screening, defined as any of the following: a. Neutrophil count \< 1.8 × 10⁹/L, b. Hemoglobin \< 110 g/L, c. Platelet count \< 50 × 10⁹/L
• •Impaired liver function, defined as any of the following: Alanine aminotransferase (ALT) \> 3 × ULN, Aspartate aminotransferase (AST) \> 3 × ULN, Total bilirubin \> 2.5 × ULN.
• •Impaired renal function: creatinine clearance rate (CrCl) \< 60 mL/min (Cockcroft-Gault formula).
• •Left ventricular ejection fraction (LVEF) \< 55%.
• •Coagulation abnormalities, defined as either: International normalized ratio (INR) \> 1.5 × ULN, Prothrombin time (PT) \> 1.5 × ULN
• •Pregnant or breastfeeding women.
• •Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.