[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589992":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":31,"interventions":38,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":69,"collaborators":71,"id":75,"slug":24,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":24,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":24,"overallStatus":57,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Lion TCR Pte. Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"Assessments of adverse events\u002Fserious adverse events","To evaluate the safety of LioCyx-M","Start of treatment until 28 days post last dose",{"measure":14,"description":15,"timeFrame":16},"Objective Response Rate (ORR)","To evaluate the anti-tumor efficacy of LioCyx-M","Up to 2 years",[18,20,22],{"measure":19,"description":15,"timeFrame":16},"Duration of Response (DoR)",{"measure":21,"description":15,"timeFrame":16},"Progression Free Survival (PFS)",{"measure":23,"description":15,"timeFrame":16},"Overall Survival (OS)",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE",[32],{"label":33,"type":34,"description":35,"interventionNames":36},"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).",[37],"Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":24},"DRUG","LioCyx-M, HBV antigen-specific TCR-redirected T cells","Via intravenous (IV) infusion",[33],[45],{"name":46,"affiliation":5,"role":47},"Tina Wang","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":24,"email":53},"Wang Zhe","CONTACT","+86 15902091916","zhe.wang@liontcr.com",[55],{"facility":56,"status":57,"city":58,"state":24,"zip":24,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Gaobo Boren Hospital","RECRUITING","Beijing","China","CN",{"type":62,"coordinates":63},"Point",[64,65],116.39723,39.9075,{"lat":65,"lon":64},[68],{"name":50,"role":51,"phone":52,"phoneExt":24,"email":53},{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[72],{"name":73,"class":74},"Beijing GoBroad Hospital","OTHER","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":85,"type":86},10,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92],"Hepatocellular Carcinoma","2025-05-06",{"date":95,"type":96},"2025-05-08","ACTUAL",{"date":98,"type":96},"2024-06-01",{"date":100,"type":86},"2028-12-01",{"name":5,"class":6},1]