[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610206":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":36,"responsibleParty":52,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":79,"overallStatus":87,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"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 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","STUDY_DIRECTOR",{"name":26,"affiliation":5,"role":24},"Corinne Summers",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":32},"Gentry King, MD","CONTACT","206-606-1024","hutchdoc@fredhutch.org; gking@fredhutch.org",{"name":34,"role":30,"phone":20,"phoneExt":20,"email":35},"Andras Heczey, MD","andras.heczey@seattlechildrens.org",[37],{"facility":38,"status":20,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fred Hutch Cancer Center","Seattle","Washington","98109","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.33207,47.60621,{"lat":48,"lon":47},[51],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":32},{"type":53,"investigatorFullName":23,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Medical Director - Seattle Children's Therapeutics","100610206","phase-1-cytokine-armored-gpc3-specific-chimeric-antigen-receptor-expressing-t-cells-in-adults-with-solid-tumors-100610206",false,"NCT07224568","Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors","INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors","INTERCEPT","1. Procurement Eligibility\n\n   Inclusion Criteria:\n   * Diagnosis of a solid tumor expressing GPC3\n   * Karnofsky score of \\>=60%\n   * Life expectancy of \\>16 weeks\n   * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative\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* 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 3 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 bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)\n* Pregnancy or lactation\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)","ALL","21 Years",{"count":66,"type":67},21,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This Phase 1, open-label, non-randomized study will enroll 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\nAn adult participant 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.",[73,74,75,76,77,78],"Solid Tumor (Excluding CNS)","Hepatocellular Carcinoma","Liver Cell Carcinoma","Liposarcoma","Yolk Sac Tumor","Rhabdomyosarcoma",[80,81,82,83,84,85,86],"CAR T cell","Adult","Non-CNS Tumor","Liver Cancer","Solid Tumor","GPC3","Glypican","NOT_YET_RECRUITING","2025-10-31",{"date":90,"type":91},"2025-11-04","ACTUAL",{"date":93,"type":67},"2026-04-01",{"date":95,"type":67},"2045-08",{"name":5,"class":6},1]