[{"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":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25,26],"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",[29,30],"Hepatitis B Virus Related Hepatocellular Carcinoma","Hepatocellular Carcinoma Recurrent",[32,33,34],"HCC","Hepatitis B Virus Related","HCC Recurrent","RECRUITING","2025-02-16",{"date":38,"type":39},"2025-02-18","ACTUAL",{"date":41,"type":39},"2022-10-26",{"date":43,"type":22},"2025-10",{"name":45,"class":46},"SCG Cell Therapy Pte. Ltd.","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100563502","phase-1-a-study-of-scg101-tcr-t-cell-therpay-in-the-treatment-of-subjects-with-hepatitis-b-virus-related-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":56,"type":22},38,[25],"This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.",[32,29,60],"Hepatocellular Carcinoma","2024-09-25",{"date":63,"type":39},"2024-09-27",{"date":65,"type":39},"2022-10-25",{"date":67,"type":22},"2025-12-31",{"name":45,"class":46},7,"Hepatitis B Virus-Related Hepatocellular Carcinoma"]