[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lion TCR Pte. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100589992","phase-1-autologous-hbv-tcr-t-cell-therapy-liocyx-m-for-the-treatment-of-hepatocellular-carcinoma-100589992",false,"NCT06961617","Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma","Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma","Inclusion Criteria:\n\n* HCC diagnosis confirmed by histology\u002F cytology or clinically\n* HCC that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and \u002For locoregional therapies\n* Has failed at least one line of systemic therapy for HCC\n* ECOG performance status ≤1\n* Serum HBsAg positivity\n* Child-Pugh A (5 - 7 points)\n* Life expectancy of at least 1 year\n* HLA profile: HLA-A\\*02:01 or HLA-A\\*24:02\n\nExclusion Criteria:\n\n* Brain metastasis\n* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors\n* Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.\n* Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration\n* Serum HBV DNA levels ≥ 200 IU\u002Fml at screening\n* Serum HBsAg levels ≥ 10,000 IU\u002Fml at screening\n* Women who are pregnant or breast-feeding","ALL","18 Years","70 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to\u002Ffailed conventional treatment.",[27],"Hepatocellular Carcinoma","RECRUITING","2025-05-06",{"date":31,"type":32},"2025-05-08","ACTUAL",{"date":34,"type":32},"2024-06-01",{"date":36,"type":21},"2028-12-01",{"name":38,"class":39},"Lion TCR Pte. Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100454265","phase-2-study-of-hbv-tcr-t-cells-liocyx-m-as-monotherapy-or-as-combination-with-lenvatinib-for-hbv-related-hcc-100454265","NCT05195294","Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC","A Multi-center, Phase 2 Study for Autologous T Cells Transfected With mRNA Encoding HBV Antigen-specific TCR (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for Advanced HBV-related Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n2. Advanced HCC with diagnosis confirmed by histology\u002F cytology or clinically by AASLD criteria in cirrhotic patients.\n3. Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and \u002For locoregional therapies\n4. Patients who failed first-line systemic therapy for HCC\n5. Serum HBsAg positivity\n6. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)\n7. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptor\n\nExclusion Criteria:\n\n1. Brain metastasis\n2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumours.\n3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples\n4. History of severe allergic anaphylactic reactions to T cell therapy products and\u002For lenvatinib\n5. Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks before the first infusion of LioCyx-M.\n6. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, tyrosine kinase inhibitor therapy, and immunotherapy.\n7. Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to first infusion. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis.\n8. Treatment with other investigational therapy within 28 days prior to initiation of study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.\n9. Likelihood to require any immunosuppressive treatments during the period of the clinical trial (Localized steroid use should be allowed)\n10. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for HBV)\n11. Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina\n12. Uncontrolled hypertension, defined as systolic blood pressure \\>160 mmHg or diastolic pressure \\>110 mmHg, despite optimal medical management","75 Years",{"count":50,"type":21},55,[52],"PHASE2","This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).",[27,55,56],"Liver Cancer, Adult","Liver Cell Carcinoma",[58,27,59,60],"TCR T cells","HBV","Hepatitis B virus","NOT_YET_RECRUITING","2025-03-05",{"date":64,"type":32},"2025-03-10",{"date":66,"type":21},"2025-03",{"date":68,"type":21},"2028-12",{"name":38,"class":39},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":48,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":40},"100419721","phase-1-redirected-hbv-specific-t-cells-in-patients-with-hbv-related-hcc-safe-t-hbv-100419721","NCT04745403","Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)","Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)","SAFE-T-HBV","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n2. Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options\n3. Serum HBsAg positivity\n4. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)\n5. Life expectancy of at least 3 months\n6. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\\*02:01 or HLA-A\\*24:02).\n\nKey Exclusion Criteria:\n\n1. Brain metastasis\n2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors\n3. Use of immune checkpoint inhibitors and\u002For tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure\n4. Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.\n5. Likelihood to require any immunosuppressive treatments during the period of the clinical trial.\n6. 7\\. Last RFA\u002FTACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV\u002FTCR T-cells\n7. Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)\n8. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.\n9. Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration\n10. Serum HBV DNA levels ≥ 200 IU\u002Fml at screening\n11. Serum HBsAg levels ≥ 10,000 IU\u002Fml at screening\n12. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples\n13. Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation\n14. Women who are pregnant or breast-feeding","21 Years",{"count":20,"type":21},[24],"This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to\u002Ffailed conventional treatment.",[27],[60,27],"2023-11-15",{"date":86,"type":32},"2023-11-18",{"date":88,"type":32},"2022-05-20",{"date":90,"type":21},"2028-07-01",{"name":38,"class":39},""]