[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618596":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":49,"collaborators":22,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":22,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":22,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"In Vivo CAR-T Therapy for Refractory Graves' Disease","EXPERIMENTAL","Participants with refractory Graves' disease will receive three to five intraveneous administrations of In Vivo CAR-T (HN2301).",[13],"Biological: In Vivo CAR-T Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","In Vivo CAR-T Therapy","Participants will receive 3 to 5 intravenous administrations of HN2301, given once every 2 days, according to the study dosing regimen.",[9],[21],"HN2301",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Jingjing JIANG, MD, PhD","CONTACT","86-021-64041990","jiang.jingjing@zs-hospital.sh.cn",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Zhongshan Hospital Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45,46],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"name":47,"role":48,"phone":22,"phoneExt":22,"email":22},"HUIJIE ZHANG, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":50,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100618596","early-phase-1-in-vivo-car-t-for-refractory-graves-disease-100618596",false,"NCT07333677","In Vivo CAR-T for Refractory Graves' Disease","A Safety and Efficacy Study of in Vivo CAR-T (HN2301) for Refractory Graves' Disease","Inclusion Criteria (Participants must meet all of the following criteria to be eligible for this study):\n\n* Age 18-75 years (inclusive), male or female.\n* 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.\n* Positive serum TRAb.\n* Willing to use effective contraception for 12 months after study drug administration.\n* 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.\n\nExclusion Criteria (Participants meeting any of the following criteria will be excluded from the study):\n\n* History of severe drug allergy or known allergic predisposition.\n* Presence or suspected presence of uncontrolled active infection.\n* History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n* Presence of significant heart disease, such as angina, myocardial infarction, heart failure, or clinically significant arrhythmias.\n* Receipt of any mRNA-LNP product or other lipid nanoparticle (LNP)-based therapy within the past 2 years.\n* Receipt of a live vaccine within 30 days prior to screening.\n* History of malignant tumors.\n* 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.\n* Presence of psychiatric disorders or severe cognitive impairment.\n* Hematologic dysfuction at screening, defined as any of the following: a. Neutrophil count \\\u003C 1.8 × 10⁹\u002FL, b. Hemoglobin \\\u003C 110 g\u002FL, c. Platelet count \\\u003C 50 × 10⁹\u002FL\n* Impaired liver function, defined as any of the following: Alanine aminotransferase (ALT) \\> 3 × ULN, Aspartate aminotransferase (AST) \\> 3 × ULN, Total bilirubin \\> 2.5 × ULN.\n* Impaired renal function: creatinine clearance rate (CrCl) \\\u003C 60 mL\u002Fmin (Cockcroft-Gault formula).\n* Left ventricular ejection fraction (LVEF) \\\u003C 55%.\n* Coagulation abnormalities, defined as either: International normalized ratio (INR) \\> 1.5 × ULN, Prothrombin time (PT) \\> 1.5 × ULN\n* Pregnant or breastfeeding women.\n* Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.","ALL","18 Years","75 Years",{"count":62,"type":63},5,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","Graves' disease is an autoimmune thyroid disorder characterized by the production of autoantibodies against the thyroid-stimulating hormone receptor (TRAb), leading to excessive thyroid hormone secretion and systemic manifestations. A subset of patients develop refractory disease, failing to achieve durable remission despite prolonged antithyroid therapy.\n\nThis study aims to evaluate the safety and efficacy of HN2301, an in vivo CAR-T therapy in which host T lymphocytes are engineered and transformed to functional CAR-T cells via CD8 antibody-coated LNP delivery of CD19 CAR-mRNA. Participants with refractory Graves' disease will receive three to five administrations of HN2301 and will be regularly monitored for changes in thyroid function, TRAb levels, clinical response, and treatment-related adverse events. The study will provide preliminary evidence on whether HN2301 can induce sustained remission of refractory Graves' disease.",[69],"Graves' Disease",[71,72,73],"refractory Graves' disease","TSH receptor antibody","in vivo CAR-T","2026-03-18",{"date":76,"type":77},"2026-03-19","ACTUAL",{"date":79,"type":77},"2026-01-29",{"date":81,"type":63},"2027-12",{"name":5,"class":6},1]