[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471365":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":77,"collaborators":19,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":19,"studyType":93,"phases":94,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"SCG Cell Therapy Pte. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCG101","EXPERIMENTAL","This is a single arm study.\n\nPatients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.",[13],"Biological: SCG101",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"SCG Cell Therapeutics","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"SCG Cell Therapy","CONTACT","(65) 68297180","clinicaltrials@scgcell.com",[31,43,48,58,63,72],{"facility":32,"status":33,"city":32,"state":32,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":19},"New York","RECRUITING","10029","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-74.00597,40.71427,{"lat":41,"lon":40},{"facility":32,"status":33,"city":32,"state":32,"zip":44,"country":35,"countryCode":36,"cosmosGeoPoint":45,"geoPoint":47,"contacts":19},"10065",{"type":38,"coordinates":46},[40,41],{"lat":41,"lon":40},{"facility":49,"status":50,"city":51,"state":19,"zip":19,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":19},"Hong Kong is.","NOT_YET_RECRUITING","Hong Kong","HK",{"type":38,"coordinates":54},[55,56],114.17469,22.27832,{"lat":56,"lon":55},{"facility":59,"status":33,"city":51,"state":19,"zip":19,"country":51,"countryCode":52,"cosmosGeoPoint":60,"geoPoint":62,"contacts":19},"Hong Kong NT",{"type":38,"coordinates":61},[55,56],{"lat":56,"lon":55},{"facility":64,"status":33,"city":64,"state":19,"zip":65,"country":64,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":19},"Singapore","169610","SG",{"type":38,"coordinates":68},[69,70],103.85007,1.28967,{"lat":70,"lon":69},{"facility":64,"status":33,"city":64,"state":19,"zip":73,"country":64,"countryCode":66,"cosmosGeoPoint":74,"geoPoint":76,"contacts":19},"228510",{"type":38,"coordinates":75},[69,70],{"lat":70,"lon":69},{"type":78,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100471365","phase-1-a-study-of-scg101-in-the-treatment-of-subjects-with-hepatitis-b-virus-related-hepatocellular-carcinoma-100471365",false,"NCT05417932","A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma","A Phase 1\u002F 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma","TCR-T","Main Inclusion Criteria:\n\n* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)\n* Subjects with HCC who have received at least 2 standard systemic therapies\n* HLA-A \\*02\n* BCLC stage B or C\n* Child-pugh score ≤ 7\n* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU\u002Fml\n* Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria\n* Life expectancy of 3 months or greater\n* Ability to provide informed consent form\n* Ability to comply with all the study procedures\n\nMain Exclusion Criteria:\n\n* Subjects with history of another primary cancer\n* Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases\n* Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection\n* Known history of neurological or mental disorder, including epilepsy or dementia\n* Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)\n* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T\u002FTCR T cell therapy\n* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)\n* Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation","ALL","18 Years","70 Years",{"count":91,"type":92},46,"ESTIMATED","INTERVENTIONAL",[95,96],"PHASE1","PHASE2","This Phase 1\u002F 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma",[99,100],"Hepatitis B Virus Related Hepatocellular Carcinoma","Hepatocellular Carcinoma Recurrent",[102,103,104],"HCC","Hepatitis B Virus Related","HCC Recurrent","2025-02-16",{"date":107,"type":108},"2025-02-18","ACTUAL",{"date":110,"type":108},"2022-10-26",{"date":112,"type":92},"2025-10",{"name":5,"class":6},6]