[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602909":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":11,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":11,"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},"Intervention Arm","EXPERIMENTAL",null,[13],"Biological: Allogeneic CAR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Allogeneic CAR-T","The participants will receive one dose of allogeneic CAR-T",[9],[21],{"name":22,"affiliation":23,"role":24},"Xiaoying LI, MD, PhD","Fudan University","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Jingjing JIANG, MD, PhD","CONTACT","86-021-64041990","jiang.jingjing@zs-hospital.sh.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Zhongshan Hospital Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},{"type":24,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Xiaoying Li","Professor","100602909","early-phase-1-allogeneic-anti-cd19-car-t-for-refractory-graves-disease-100602909",false,"NCT07129642","Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease","The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease","Inclusion Criteria:\n\n* Subjects with refractory Graves disease, which is defined as meeting any one of the following criteria: a. Failure to discontinue medication after continuous standard antithyroid therapy for ≥ 3 years; b. Hyperthyroid state requiring medication after receiving ≥ 2 times of radioiodine therapy (with the last dose of radioiodine administered at least 6 months prior); c. Relapse ≥ 2 times after cessation of medication upon meeting the criteria for treatment discontinuation.\n* Serum TRAb ≥ 3 times greater than normal range (≥ 5 IU\u002FL)\n* Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n* Participation in this clinical study is willing to sign an informed consent with good compliance with treatment and follow-up.\n\n(Criteria for treatment discontinuation is define as receiving continuous anti-thyroid drug therapy for ≥18 months, and maintaining euthyroid status for ≥6 months, plus negative TRAb and TSI. Relapse is defined as recurrence of hyperthyroidism and positive TRAb\u002FTSI after meeting the criteria for treatment discontinuation and stopping medication.)\n\nExclusion Criteria:\n\n* History of severe drug allergies or allergic constitution;\n* Presence or suspicion of uncontrolled infections requiring intravenous treatment (fungal, bacterial, viral or other);\n* Presence of central nervous system disorders (including epilepsy, psychosis, cerebrovascular accident, encephalitis, CNS vasculitis, etc);\n* Presence of clinically significant heart diseases (e.g., angina pectoris, myocardial infarction, heart failure, severe arrhythmias, etc);\n* Subjects with congenital immunoglobulin deficiency;\n* Patients with malignant tumors;\n* Subjects who are: 1. HBsAg or HBcAb positive with detectable peripheral blood HBV DNA; 2. HCV antibody positive with detectable HCV RNA; 3. Positive HIV antibody; 4. Syphilis test positive;\n* Subjects with psychiatric disorders or severe cognitive dysfunction;\n* Hematopoietic function: a. White blood cell count \\\u003C 3.5×10\\^9\u002FL b. Neutrophil count \\\u003C 1.5 x 10\\^9\u002FL; c. Hemoglobin \\\u003C 110g\u002FL.\n* Liver function: ALT\\> 3×ULN, AST \\> 3×ULN, TBIL \\> 2.5×ULN.\n* Renal function: creatinine clearance rate (CrCl) \\\u003C 60 ml\u002Fminute (calculated based on Cockcroft\u002FFault formula).\n* Cardiac function: LVEF \\\u003C 55%\n* Coagulation function: International standardized ratio (INR) ≥ 1.5×ULN, prothrombin time(PT) \\>1.5 × ULN.\n* Participation in other clinical trials within 3 months prior to enrollment;\n* Pregnancy or planning pregnancy;\n* Other conditions considered by investigators as unsuitable for participation.","ALL","18 Years","65 Years",{"count":62,"type":63},5,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","Graves' disease is an autoimmune disease. The TSH receptor antibody(TRab) produced by B cells drives the production of thyroid hormone, which causes systemic disorders and thyroid eye disease. The purpose of this study is to investigate the efficacy and safety of allogeneic anti-CD19 CAR-T for refractory Graves' disease.\n\nThe participants with refractory Graves' disease will receive a single dose of allogeneic anti-CD19 CAR-T and be regularly seen for the change of serum TRab, FT3, FT4 and clinical presentations, as well as any adverse events.",[69],"Graves Disease",[71,72,73],"CAR-T","refractory Graves disease","TSH receptor antibody","2025-08-16",{"date":76,"type":77},"2025-08-19","ACTUAL",{"date":79,"type":63},"2025-08-10",{"date":81,"type":63},"2027-03-31",{"name":5,"class":6},1]