[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464092":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":37,"locations":38,"responsibleParty":67,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":37,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":37,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":40,"whyStopped":37,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The Affiliated Hospital of Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"fhB7H3.CAR-T cells","EXPERIMENTAL","In phase I study , 9 enrolled patients diagnosed with advanced liver cancer will receive one-time transhepatic arterial infusion of fhB7H3.CAR-Ts at the doses of 1×10\\^6\u002Fkg, 3×10\\^6\u002Fkg and 5×10\\^6\u002Fkg, 3 patients for each dose. To further confirm the therapeutic efficacy, in phase II study, 6 enrolled patients will receive an optimal dose (balancing effectiveness and toxicity) of fhB7H3.CAR-Ts.",[13,14,15],"Biological: fhB7H3.CAR-Ts","Drug: Fludarabine","Drug: Cyclophosphamide",[17,24,31],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","fhB7H3.CAR-Ts","fhB7H3.CAR-Ts will be transhepatic arterial infused after lymphodepletion. Three dose levels will be evaluated: Dose Level 1 (1×10\\^6\u002Fkg), dose Level 2 (3×10\\^6\u002Fkg) and dose Level 3 (5×10\\^6\u002Fkg). If dose limiting toxicities (DLTs) are observed in each doses, Dose Level -1 (0.5×10\\^6\u002Fkg \u002Finfusion) will be evaluated.",[9],[23],"B7H3 targeting chimeric antigen receptor T cells",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Fludarabine","30 mg\u002Fm2 i.v. for 3 consecutive days (Day -5\\~Day -3)",[9],[30],"FLUDARA",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Cyclophosphamide","750 mg\u002Fm2 i.v. for once (Day -5)",[9],[36],"Cytoxan",null,[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Xuzhou","Jiangsu","221002","China","CN",{"type":47,"coordinates":48},"Point",[49,50],117.28386,34.20442,{"lat":50,"lon":49},[53,58,61,64],{"name":54,"role":55,"phone":56,"phoneExt":37,"email":57},"Yong Wang, M.D.","CONTACT","+86-516-83353391","mumei20071115@163.com",{"name":59,"role":55,"phone":56,"phoneExt":37,"email":60},"Yan Li, M.D.","505620539@qq.com",{"name":62,"role":63,"phone":37,"phoneExt":37,"email":37},"Wei Xu, M.D.","PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":37,"phoneExt":37,"email":37},"Gang Wang, Ph.D.","SUB_INVESTIGATOR",{"type":68,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[70,72],{"name":71,"class":6},"Xuzhou Medical University",{"name":73,"class":74},"IIT MediTech Co. Ltd","UNKNOWN","100464092","phase-1-study-of-b7h3-car-t-cells-in-treating-advanced-liver-cancer-100464092",false,"NCT05323201","Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer","A Single-Arm, Open-Label Study to Evaluate Safety and Efficacy of B7H3 or HBsAg Targeting CAR-T in Treating Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Subjects should be 18-70 years old.\n2. Subject has adequate performance status as defined by ECOG score of≤ 2.\n3. Expected life expectancy is no less than 12 weeks.\n4. Subjects must have histologically or cytologically confirmed unresectable, recurrent and \u002F or metastatic hepatocellular carcinoma (HCC). And tumor tissues are measured positive for B7H3 expression.\n5. Child-Pugh A, B grade.\n6. Blood routine:\n\n   white blood cell count≥ 2.5 × 10\\^9 \u002F L; hemoglobin≥ 9 g\u002FdL; platelet count≥ 50 × 10\\^9 \u002F L; lymphocyte proportion≥ 15 %;\n7. Adequate organ function. Patients' main organs ( heart, lung, liver, kidney, etc. ) function well:\n\n   ALT and AST≤ 5 × ULN; ALB≥ 30 g\u002FL； Total bilirubin≤ 2.5 × ULN； Serum creatinine\\\u003C 220μmol\u002FL; Indoor oxygen saturation ≥ 95 %; Left ventricular ejection fraction≥ 40%;\n8. No allergic reaction to contrast agents.\n9. Procurement and T-cell production eligibility: a previously evaluation confirmed autologous peripheral blood mononuclear cells can be used for T-cell production.\n10. Patients or their legal guardians voluntarily participate in and sign the informed consent form.\n\nExclusion Criteria:\n\n1. The subject is a pregnant or lactating woman.\n2. The subjects have infectious diseases (such as HIV, syphilis, active tuberculosis, etc.);\n3. The subject has active infection or coagulation dysfunction.\n4. Subjects with previous hepatic encephalopathy.\n5. The subject is on anticoagulation or antiplatelet therapy.\n6. The subject is an organ transplant or waiting for transplant.\n7. Subjects with mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation.\n8. The subjects are highly allergic or have a history of severe allergies.\n9. The subject has received chemotherapy\u002Fradiotherapy within the past 4 weeks.\n10. The subject has a history of cellular immunotherapy or antibody therapy.\n11. The subject is receiving systemic hormone therapy.\n12. Subjects with systemic infection or severe local infection requiring anti-infection treatment.\n13. The subject has dysfunction of important organs such as heart, lung, brain, liver, and kidney.\n14. The subject is participating in other clinical research.\n15. The doctor believes that there are other reasons not to be included in the treatment.\n16. Unwilling or unable to provide consent\u002Fassent for participation in the study.","ALL","18 Years","70 Years",{"count":86,"type":87},15,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE1","PHASE2","This is single center, open-label phase I\u002FII, non-randomized study which will enroll patients with recurrent advanced hepatocellular carcinoma to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T in treating hepatocellular carcinoma.",[94],"Hepatocellular Carcinoma",[96,97],"Fully human B7H3 CAR-T","Recurrent Advanced Hepatocellular Carcinoma","2022-04-05",{"date":100,"type":101},"2022-04-12","ACTUAL",{"date":103,"type":101},"2022-02-10",{"date":105,"type":87},"2027-02-10",{"name":5,"class":6},1]