[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630851":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Guangzhou FineImmune Biotechnology Co., LTD.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation was performed in a 3+3 design","EXPERIMENTAL","The Super CAR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3",[13],"Biological: Super CAR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Super CAR-T","All participators received lymphoid-depleted preconditioning before Super CAR-T cells infusion.\n\nSuper CAR-T cells were infused 3 days later.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"BINKUI LI, Professor","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"YING CHENG","CONTACT","86-02031605836","chengy02@fineimmu.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Gaungdong","510700","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48],{"name":23,"role":29,"phone":49,"phoneExt":20,"email":50},"86-02087343114","libk@sysucc.org.cn",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54],{"name":24,"class":55},"OTHER","100630851","phase-1-an-open-label-phase-i-clinical-trial-of-super-car-t-with-gpc3-positive-advanced-hepatocellular-carcinoma-100630851",false,"NCT07493044","An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma","An Open-Label, Phase I Clinical Trial of GPC3-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (Super CAR-T) for the Treatment of Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;\n2. Be between 18 and 75 years of age; gender is not restricted;\n3. Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;\n4. Previous failure of or intolerance to at least two lines of standard systemic therapy;\n5. The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;\n6. At least one measurable lesion according to RECIST 1.1 criteria;\n7. ECOG performance status of 0-1;\n8. Expected survival of more than 3 months;\n9. Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%;\n10. Laboratory test results must meet at least the following criteria:\n\n    ANC ≥1.0×10⁹\u002FL; PLT ≥75×10⁹\u002FL; Hb ≥ 75 g\u002FL; Creatinine clearance ≥ 60 mL\u002Fmin; AST ≤ 5×ULN; ALT≤ 5×ULN; TBIL ≤ 3×ULN;\n11. If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU\u002FmL;\n12. Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment.\n\nExclusion Criteria:\n\n1. The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;\n2. The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;\n3. Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;\n4. Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);\n5. Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;\n6. Received systemic glucocorticoid therapy within 7 days prior to single-plasma donation; patients currently using or who have recently used inhaled or topical glucocorticoids, as well as those on physiological-dose replacement therapy, are eligible for enrollment;\n7. Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment;\n8. Known active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, multiple sclerosis, and glomerulonephritis (patients with vitiligo are not excluded);\n9. History of organ transplantation, autologous\u002Fallogeneic stem cell transplantation, or renal replacement therapy;\n10. HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive;\n11. Currently pregnant or breastfeeding, or planning to become pregnant during the study;\n12. Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.","ALL","18 Years","75 Years",{"count":67,"type":68},15,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.",[74,75],"Advanced Hepatocellular Carcinoma (HCC)","GPC3 Positive Hepatocellular Carcinoma",[77,78,79,80],"GPC3 CAR-T","Cell therapy","Immunotherapy","Hepatocellular Carcinoma","2026-05-12",{"date":83,"type":84},"2026-05-14","ACTUAL",{"date":86,"type":84},"2026-03-27",{"date":88,"type":68},"2028-07-30",{"name":5,"class":6},1]