[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-virus-related-hepatocellular-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-virus-related-hepatocellular-carcinoma":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24,25],"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",[28,29],"Hepatitis B Virus Related Hepatocellular Carcinoma","Hepatocellular Carcinoma Recurrent",[31,32,33],"HCC","Hepatitis B Virus Related","HCC Recurrent","RECRUITING","2025-02-16",{"date":37,"type":38},"2025-02-18","ACTUAL",{"date":40,"type":38},"2022-10-26",{"date":42,"type":21},"2025-10",{"name":44,"class":45},"SCG Cell Therapy Pte. Ltd.","INDUSTRY",6,{"id":48,"slug":4,"hasResults":10,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100563502","NCT06617000","A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related","A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)\n* Subjects with HCC who have received standard systemic therapies\n* HLA-A \\*02\n* BCLC stage B or C\n* Child-pugh score ≤ 7 ol\n* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU\u002Fml\n* Have at least one measurable leasion at baseline as per mRECIST and iRECIST\n* Life expectancy of 3 months or greater\n* The organ function is in good condition.\n\nExclusion Criteria:\n\n* Subjects with history of another primary cancer within 5 years\n* Central nervous system metastasis and clinically significant central nervous system disease\n* Previous or current coexistence of hepatic encephalopathy\n* Currently present with symptomatic third space fluid accumulation\n* Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)\n* Known history of neurological or mental disorder, including epilepsy or dementia\n* Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis\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\n* Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection\n* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation",{"count":54,"type":21},38,[24],"This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.",[31,28,58],"Hepatocellular Carcinoma","2024-09-25",{"date":61,"type":38},"2024-09-27",{"date":63,"type":38},"2022-10-25",{"date":65,"type":21},"2025-12-31",{"name":44,"class":45},7,""]