[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604325":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":36,"responsibleParty":57,"collaborators":20,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":88,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Seattle Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SC-CAR.GPC3xIL15.21 T cells","EXPERIMENTAL","Autologous SC-CAR.GPC3xIL15.21 T cell product will be infused as a single infusion.",[13],"Biological: SC-CAR.GPC3xIL15.21 CAR T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","SC-CAR.GPC3xIL15.21 CAR T cells","Autologous SC-CAR.GPC3xIL15.21 T cell products infusion",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Colleen Annesley, MD","STUDY_DIRECTOR",{"name":26,"affiliation":5,"role":24},"Corinne Summers, MD",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":32},"Michelle Choe, MD","CONTACT","206-987-2106","immunotherapy@seattlechildrens.org",{"name":34,"role":30,"phone":20,"phoneExt":20,"email":35},"Andras Heczey, MD","Andras.Heczey@seattlechildrens.org",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Seattle","Washington","98105","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.33207,47.60621,{"lat":48,"lon":47},[51,53,55],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":52},"michelle.choe@seattlechildrens.org",{"name":34,"role":30,"phone":20,"phoneExt":20,"email":54},"andras.heczey@seattlechildrens.org",{"name":29,"role":56,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Colleen Annesley","Medical Director - Seattle Children's Therapeutic","100604325","phase-1-immunotherapy-for-solid-tumor-malignancies-in-pediatrics-using-interleukin-15-and--21-armored-glypican-3-specific-chimeric-antigen-receptor-t-cells-100604325",false,"NCT07148050","Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells","IMPACT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Lansky or Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\n   For patients with hepatocellular carcinoma only:\n   * Barcelona Liver Cancer Stage A, B or C\n   * Child-Pugh Turcotte Score \\\u003C7\n\n   Exclusion Criteria:\n   * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n     * History of organ transplantation\n     * Known HIV positivity\n     * Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n2. Treatment eligibility\n\nInclusion Criteria:\n\n* Lansky or Karnofsky score of \\>=60%\n* Life expectancy of \\>16 weeks\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n* Adequate organ function\n* Adequate laboratory values\n* Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian.\n\nFor patients with hepatocellular carcinoma only:\n\n* Barcelona Liver Cancer Stage A, B or C\n* Child-Pugh Turcotte Score \\\u003C7\n\nExclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.\n\n  * History of organ transplantation\n  * Known HIV positivity\n* Active autoimmune or inflammatory disorder\n* Live vaccines within 30 days prior to enrollment\n\n  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\n* Uncontrolled infection\n* Systemic steroid treatment (≥ 0.5 mg prednisone equivalent\u002Fkg\u002Fday, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.","ALL","1 Year","26 Years",{"count":71,"type":72},21,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells).\n\nA child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.",[78,79,80,81,82,83,84,85,86,87],"Solid Tumor (Excluding CNS)","Liver Cell Carcinoma","Malignant Rhabdoid Tumor","Yolk Sac Tumor","Liposarcoma","Rhabdomyosarcoma","Embryonal Sarcoma of Liver","Wilms Tumor","Hepatocellular Carcinoma","Hepatoblastoma",[89,90,91,92,93,94,95,96],"CAR T cell","Pediatric","Young Adult","Non-CNS Tumor","Liver Cancer","Solid Tumor","GPC3","Glypican","2026-02-13",{"date":99,"type":100},"2026-02-17","ACTUAL",{"date":102,"type":100},"2025-12-22",{"date":104,"type":72},"2044-04-22",{"name":5,"class":6},1]