[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SCG Cell Therapy Pte. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":112},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,70],{"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,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":89,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100554935","phase-1-phase-12-study-of-autologous-scg142-tcr-t-cells-in-patients-with-hpv1652-positive-carcinoma-100554935","NCT06505551","Phase 1\u002F2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16\u002F52-positive Carcinoma","A Phase 1\u002F2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas","Main Inclusion Criteria:\n\n1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.\n2. Tumor tissue positive for HPV16 or HPV52.\n3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy.\n4. Human leukocyte antigen (HLA)-A\\*02:01 genotype.\n5. Measurable disease as defined by RECIST v1.1.\n6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.\n7. Anticipated life expectancy ≥3 months.\n8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.\n\nMain Exclusion Criteria:\n\n1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.\n2. Active brain metastasis or leptomeningeal metastases.\n3. History of other malignancy within 2 years prior to Screening.\n4. History of organ transplant.\n5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n6. History of active cardiac disease.\n7. History of active pulmonary disease.\n8. Active, known, or suspected autoimmune disease.\n9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.\n10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR\u002FTCR-T cell therapy.\n11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and\u002For any component of SCG142.\n12. Any serious medical condition or abnormality in clinical laboratory tests.",{"count":78,"type":22},66,[25,26],"This is a phase 1\u002F2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and\u002For combination chemo-immunotherapy",[82,83,84,85,86,87,88],"HPV-Related Squamous Cell Carcinoma","HPV-Related Cervical Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vaginal Squamous Cell Carcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Head and Neck Cancer",[90,91,92,93,94,95,96,97,98,99,100,101,102],"Human Papilloma Virus","HPV","Cervical Cancer","Head and Neck Cancer","Oropharyngeal Cancer","Vulvar Cancer","Vaginal Cancer","Penile Cancer","Anal Cancer","Anogenital Cancer","TCR T Cell","Cell therapy","T cell receptor T cell","NOT_YET_RECRUITING","2024-07-10",{"date":106,"type":39},"2024-07-17",{"date":108,"type":22},"2024-10",{"date":110,"type":22},"2028-12",{"name":45,"class":46},""]