[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589992":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Lion TCR Pte. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LioCyx-M","EXPERIMENTAL","LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10\\^6 cells\u002Fkg body weight (BW).",[13],"Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","LioCyx-M, HBV antigen-specific TCR-redirected T cells","Via intravenous (IV) infusion",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Tina Wang","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Wang Zhe","CONTACT","+86 15902091916","zhe.wang@liontcr.com",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Gaobo Boren Hospital","RECRUITING","Beijing","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[49],{"name":50,"class":51},"Beijing GoBroad Hospital","OTHER","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":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70],"Hepatocellular Carcinoma","2025-05-06",{"date":73,"type":74},"2025-05-08","ACTUAL",{"date":76,"type":74},"2024-06-01",{"date":78,"type":64},"2028-12-01",{"name":5,"class":6},1]