[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419721":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":48,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Lion TCR Pte. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"mRNA HBV\u002FTCR T-cells","EXPERIMENTAL","Escalating regime from 1x10e5 to 5-10x10e6 cells\u002Fkg bodyweight (BW) every 2 weeks.",[13],"Drug: mRNA HBV\u002FTCR T-cells",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Study Infusion\n\nThe first dose of mRNA HBV-TCR T-cells at dose 1x10e5\u002Fkg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6\u002Fkg BW.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Royce Fam","CONTACT","69260818","royce.fam@liontcr.com",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":31,"country":30,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Singapore General Hospital","RECRUITING","Singapore","169608","SG",{"type":34,"coordinates":35},"Point",[36,37],103.85007,1.28967,{"lat":37,"lon":36},[40,44,46],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Thinesh L Krishnamoorthy","62223322","thinesh.l.krishnamoorthy@singhealth.com.sg",{"name":19,"role":23,"phone":19,"phoneExt":45,"email":43},"Krishnamoorthy",{"name":41,"role":47,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100419721","phase-1-redirected-hbv-specific-t-cells-in-patients-with-hbv-related-hcc-safe-t-hbv-100419721",false,"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","ALL","21 Years","75 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","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.",[69],"Hepatocellular Carcinoma",[71,69],"Hepatitis B virus","2023-11-15",{"date":74,"type":75},"2023-11-18","ACTUAL",{"date":77,"type":75},"2022-05-20",{"date":79,"type":63},"2028-07-01",{"name":5,"class":6},1]