[{"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":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"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","phase-1-safety-and-efficiency-of-the-universal-cnk-ut009-in-difficult-to-treat-inflammatory-bowel-disease-patients-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":39,"type":40},40,"ESTIMATED","INTERVENTIONAL",[43],"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.",[46,47,48],"Inflamatory Bowel Disease","Crohn Disease (CD)","Ulcerative Colitis (UC)","NOT_YET_RECRUITING","2026-02-14",{"date":52,"type":53},"2026-02-18","ACTUAL",{"date":55,"type":40},"2026-04-01",{"date":57,"type":40},"2031-12-31",{"name":5,"class":6}]