[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626449":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":49,"collaborators":31,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":31,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":31,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BCMA CAR-T or CD19 CAR-T or CD19×BCMA","EXPERIMENTAL","Autologous BCMA\u002FCD19\u002FCD19×BCMA-targeting CAR T cells",[13],"Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMA",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Autologous BCMA\u002FCD19\u002FCD19×BCMA-targeting CAR T cells, dosage 1\\*10\\^6\u002Fkg, intravenous injection once",[9],[20],"Biological: BCMA\u002FCD19\u002FCD19×BCMA CAR-T",[22],{"name":23,"affiliation":24,"role":25},"Jianping Wang","Foresea Life Insurance Guangzhou General Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Yingdi Chen","CONTACT","13763381162",null,"chenyd193@163.com",[34],{"facility":24,"status":35,"city":36,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Guangzhou","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.25,23.11667,{"lat":43,"lon":42},[46,47],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":28,"role":48,"phone":31,"phoneExt":31,"email":31},"SUB_INVESTIGATOR",{"type":50,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100626449","early-phase-1-autologous-car-t-cell-therapy-for-refractory-and-relapsing-ulcerative-colitis-a-single-center-exploratory-study-100626449",false,"NCT07435779","Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study","A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis","Inclusion Criteria:\n\n* The subject or guardian must provide voluntary informed consent;\n* Diagnosis based on the \"Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)\": Patients diagnosed with UC (based on comprehensive evaluation including clinical, imaging, pathological, and endoscopic assessments), with a follow-up period of more than 3 months;\n* Moderate to severe active ulcerative colitis: Patients meeting the criteria of a clinical modified Mayo score of 6-12 points and an endoscopic Mayo score (ES) ≥ 2 points (within 10 days prior to baseline);\n* Previous treatments with all domestically approved medications for UC, including conventional immunosuppressive drugs, biologics, and small molecule drugs, have failed;\n* Hematological, liver and kidney function, cardiopulmonary function, and coagulation function meet specific criteria.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating;\n* Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results;\n* Diagnosed with CD (Crohn's Disease) or indeterminate colitis (IBD-unclassified), or other types of colitis or enteritis that may confound efficacy assessment;\n* Currently diagnosed with fulminant colitis and\u002For toxic megacolon;\n* UC limited to the rectum;\n* Currently or likely to require colostomy or ileostomy;\n* Has previously undergone total proctocolectomy or partial colectomy.\n* Patients who test positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, and peripheral blood HBV DNA is above the detection limit, they should be excluded; patients who test positive for hepatitis C virus (HCV) antibodies and HCV RNA should be excluded; patients who test positive for human immunodeficiency virus (HIV) antibodies; patients who test positive for cytomegalovirus (CMV) DNA; patients who test positive for Epstein-Barr virus (EBV) DNA; patients who test positive for both treponemal-specific antibodies and non-specific antibodies for syphilis should be excluded.\n* Any uncontrolled active infection present at the time of signing the ICF.\n* Subjects who have had severe, opportunistic, or chronic\u002Frecurrent extra-intestinal infections within 2 months prior to screening; evidence of active\u002Finfectious herpes zoster infection within 8 weeks prior to screening; active tuberculosis or latent tuberculosis infection present at screening.","ALL","18 Years","60 Years",{"count":62,"type":63},12,"ESTIMATED","INTERVENTIONAL",[66],"EARLY_PHASE1","A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection in Refractory and Relapsing Ulcerative Colitis.",[69],"UC",[71],"UC；CAR-T","2026-02-25",{"date":74,"type":75},"2026-02-27","ACTUAL",{"date":77,"type":75},"2026-02-04",{"date":79,"type":63},"2028-02-04",{"name":5,"class":6},1]