[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uc":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"UC",[29],"UC；CAR-T","RECRUITING","2026-02-25",{"date":33,"type":34},"2026-02-27","ACTUAL",{"date":36,"type":34},"2026-02-04",{"date":38,"type":21},"2028-02-04",{"name":40,"class":41},"Hebei Senlang Biotechnology Inc., Ltd.","INDUSTRY",""]