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This study examines an in vivo CAR-T therapy in patients with treatment-refractory Graves' disease. It enrolls participants aged 18 to 75 who meet the definition of refractory Graves' disease and have a positive serum TRAb test. The study is in Early Phase 1 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria (Participants must meet all of the following criteria to be eligible for this study): * Age 18-75 years (inclusive), male or female. * Refractory Graves' disease, defined as meeting at least one of the following: a) Continuous antithyroid drug (ATD) therapy for ≥3 years without achieving criteria for ATD discontinuation; b) Meeting criteria for ATD discontinuation but experiencing ≥2 relapses after ATD withdrawal. * Positive serum TRAb. * Willing to use effective contraception for 12 months after study drug administration. * Voluntarily agrees to participate in the study, has signed the informed consent form, and is able to comply with study procedures and follow-up requirements. Exclusion Criteria (Participants meeting any of the following criteria will be excluded from the study): * 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.