[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610206":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":27,"locations":36,"responsibleParty":51,"collaborators":20,"id":54,"slug":20,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":20,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"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,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Fred Hutch Cancer Center","Seattle","Washington","98109","United States",{"type":44,"coordinates":45},"Point",[46,47],-122.33207,47.60621,{"lat":47,"lon":46},[50],{"name":29,"role":30,"phone":31,"phoneExt":20,"email":32},{"type":52,"investigatorFullName":23,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Medical Director - Seattle Children's Therapeutics","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":64,"type":65},21,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71,72,73,74,75,76],"Solid Tumor (Excluding CNS)","Hepatocellular Carcinoma","Liver Cell Carcinoma","Liposarcoma","Yolk Sac Tumor","Rhabdomyosarcoma",[78,79,80,81,82,83,84],"CAR T cell","Adult","Non-CNS Tumor","Liver Cancer","Solid Tumor","GPC3","Glypican","NOT_YET_RECRUITING","2025-10-31",{"date":88,"type":89},"2025-11-04","ACTUAL",{"date":91,"type":65},"2026-04-01",{"date":93,"type":65},"2045-08",{"name":5,"class":6},1]