[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624957":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":11,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":11,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":11},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CNK-UT009 injection","EXPERIMENTAL",null,[13],"Drug: injection of CNK-UT009",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","injection of CNK-UT009","CNK-UT009 is a type of independent development universal cell therapy agent, the reagent would be injected intravenously. We set three preset dose levels (3\\*7E positive cells\u002Fkg 、6\\*7E positive cells\u002Fkg 和 1\\*8E positive cells\u002Fkg) with a tapering dose of 1.5\\*7E positive cells\u002Fkg. Total cells would be divided into several parts and be given in the cycle of two weeks, adjusted by the tolerance and adverse effects of our patients.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yan Chen, Doctor","CONTACT","+86 13757118653","chenyan72_72@zju.edu.cn",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624957",false,"NCT07416383","Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients","An Exploratory Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetics of the Universal CNK-UT009 Cell Injection in Subjects With Difficult-to-treat Inflammatory Bowel Disease","Inclusion Criteria:\n\n* diagnosed moderate-to- severe IBD patients\n* defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)\n* with complete bone-marrow and organic function\n* no pregnant or planning to become pregnant\n* welling to paticipate\n\nExclusion Criteria:\n\n* patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)\n* patients paticipated other clinical trials with four weeks\n* patients with drug combination other than low-dose glucocotiod\n* patients recieved abdominal surgery or live vaccine\n* patients with planned surgery in three months\n* unsuitable situations determined by researchers","ALL","18 Years","65 Years",{"count":38,"type":39},40,"ESTIMATED","INTERVENTIONAL",[42],"PHASE1","Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.",[45,46,47],"Inflamatory Bowel Disease","Crohn Disease (CD)","Ulcerative Colitis (UC)","NOT_YET_RECRUITING","2026-02-14",{"date":51,"type":52},"2026-02-18","ACTUAL",{"date":54,"type":39},"2026-04-01",{"date":56,"type":39},"2031-12-31",{"name":5,"class":6}]