[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588434":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":19},{"fullName":5,"class":6},"Nuwacell Biotechnologies Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NCR102 injection","EXPERIMENTAL","Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection",[13],"Biological: NCR102 injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yanqiu Li","CONTACT","400-888-2032","yqli@nuwacell.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100588434","phase-1-a-trial-to-evaluate-the-safety-and-efficacy-of-ncr102-in-subjects-with-agvhd-100588434",false,"NCT06941350","A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD","A Phase I\u002FII Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)","Inclusion Criteria:\n\n* Age\\>18 years and \\\u003C70 years old (including threshold), gender not limited；\n* Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；\n* Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；\n* Failed to second-line aGVHD treatment;\n* Subjects will receive NCR102 injection treatment within 3 days after enrollment;\n* Voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n* Subjects have lung disease, and investigators have determined that they are not suitable for the study;\n* Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;\n* Subjects with signs\u002Fsymptoms of chronic GVHD;\n* Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;\n* Eastern Cooperative Oncology Group(ECOG)\\>3；\n* Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；\n* Subjects had active malignant solid tumors within the past 5 years；\n* Subjects had a known history of severe allergies to blood products, or heterologous proteins.","ALL","18 Years","70 Years",{"count":39,"type":40},24,"ESTIMATED","INTERVENTIONAL",[43,44],"PHASE1","PHASE2","Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.",[47],"Acute Graft-versus-Host Disease",[49,50,51],"SR-aGVHD","NCR102","second-line treatment failure","NOT_YET_RECRUITING","2025-04-16",{"date":55,"type":56},"2025-04-23","ACTUAL",{"date":58,"type":40},"2025-04-28",{"date":60,"type":40},"2027-05-30",{"name":5,"class":6}]