[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eureka Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100428822","phase-1-gpc3-targeted-t-cell-therapy-ect204-in-adults-with-advanced-hcc-100428822",false,"NCT04864054","GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of ECT204 T-Cell Therapy in Adults With Advanced Hepatocellular Carcinoma (HCC)","ARYA-3","Inclusion Criteria:\n\n* Histologically confirmed HCC, that is unresectable, recurrent, and\u002For metastatic.\n* GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).\n\n  * For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.\n  * Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+\u002F3+ IHC.\n* Must have received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.\n* Life expectancy of at least 4 months per the Investigator's opinion.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Measurable disease by RECIST v1.1.\n* Child-Pugh score of A6 or better.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancies with low risk of recurrence.\n* Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease. Subjects with brain metastases that have been adequately treated (no evident neurological deficit and no steroid or anti-epileptic therapy for brain metastases) are eligible.\n* Pregnant or lactating women.\n* Currently receiving or ending (\\\u003C 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.\n* Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.\n* Active autoimmune disease requiring systemic immunosuppressive therapy.\n* Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC), except for subjects with IVC invasion who have been treated and radiographically stable for at least 6 months prior to screening.\n* Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: Subjects maintained on a stable dose of diuretics with controlled, asymptomatic ascites are eligible.\n* Active gastrointestinal (GI) bleeding event ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 5.0, within 6 months prior to screening.\n* Coagulation abnormality defined as international normalized ratio (INR) \\> 1.7, unless the elevation is due to therapeutic anticoagulation that, in the Investigator's judgment, can be safely managed in the context of study procedures.\n* History of organ transplant.\n* HCC involving greater than 50% of the liver volume.\n* Experienced allergies to any component of the study drug (ECT204), mouse immunoglobulin, or iron-dextran, or have a history of severe hypersensitivity, including anaphylaxis.\n* Previously received other gene therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T\\] therapy); exception: prior oncolytic virus therapy is permitted.).\n* Contraindication for undergoing leukapheresis procedure or receipt of conditioning agents","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is an open-label, multi-center, Phase 1\u002F2 clinical trial evaluating the safety, tolerability, and efficacy of ECT204, an investigational ARTEMIS® T-cell therapy, in adult subjects with GPC3-positive hepatocellular carcinoma (HCC) who have experienced disease progression on, or intolerance to, prior systemic therapy.",[28,29,30,31],"Hepatocellular Carcinoma","Liver Cancer, Adult","Liver Neoplasm","Metastatic Liver Cancer",[28,33,34,35,30,31,36,37,38,39],"Advanced HCC","Late-Stage HCC","Liver Cancer","Metastatic HCC","T-cell therapy","Immunotherapy","HCC","RECRUITING","2026-06-05",{"date":43,"type":44},"2026-06-09","ACTUAL",{"date":46,"type":44},"2022-03-11",{"date":48,"type":21},"2027-12-31",{"name":50,"class":51},"Eureka Therapeutics Inc.","INDUSTRY",8,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":5},"100411195","phase-1-et140203-t-cells-in-pediatric-subjects-with-hepatoblastoma-hcn-nos-or-hepatocellular-carcinoma-100411195","NCT04634357","ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma","An Open-Label, Dose Escalation, Phase I\u002FII Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed\u002FRefractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)","ARYA-2","Inclusion Criteria:\n\n1. Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \\>100ng\u002FmL at the time of screening and following the most recent line of therapy.\n2. Disease reoccurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).\n3. Age ≥ 1 year and ≤ 21 years.\n4. Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.\n5. Life expectancy of \\> 4 months per the Investigator's opinion.\n6. Lansky or Karnofsky Performance Scale ≥ 70.\n7. For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n8. Child-Pugh score of A6 or better.\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).\n2. Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness\u002Fsocial situation that would limit compliance with study requirements.\n3. Active, uncontrolled systemic bacterial, fungal, or viral infection. Subjects with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n4. Any known active malignancy (other than HB, HCN-NOS, or HCC).\n5. Pregnant or lactating women.\n6. Received the following within two (2) weeks of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), immunosuppressive therapy, or systemic corticosteroids at doses greater than 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids. (Note: Topical and inhaled corticosteroids in standard doses and physiological replacement doses of corticosteroids for adrenal insufficiency are allowed).\n7. Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.\n8. Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.\n9. Active autoimmune disease requiring systemic immunosuppressive therapy.\n10. Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.\n11. History of organ transplant.\n12. HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).","1 Year","21 Years",{"count":64,"type":21},15,[24,25],"Open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety\u002Ftolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive\u002FHLA-A2-positive and have relapsed\u002Frefractory HB, HCN-NOS, or HCC.",[68,69,70,31,35,71],"Hepatoblastoma","Hepatocellular Carcinoma (HCC)","Liver Neoplasms","HEMNOS",[73,74,75,69,35,37,31,76,71],"Relapsed\u002FRefractory Hepatoblastoma (HB)","Pediatric","Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS)","Liver neoplasms","2025-04-07",{"date":79,"type":44},"2025-04-09",{"date":81,"type":44},"2022-07-19",{"date":83,"type":21},"2028-01-31",{"name":50,"class":51},""]