[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vironexis Biotherapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100607736","phase-1-gene-therapy-for-her-positive-cancer-sentry-her2-100607736",false,"NCT07192432","Gene Therapy for HER-Positive Cancer (SENTRY-HER2)","A Phase 1\u002F2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer","SENTRY-HER2","Inclusion Criteria:\n\n* Age: ≥18 years of age\n* Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol\n* Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment\n* Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment\n* AAV specified capsid total antibody ≤1:400\n* ECOG performance status of 0 or 1\n* Life expectancy ≥3 months\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* Known active CNS or leptomeningeal disease\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* History of other malignancy within 5 years prior to screening as defined in protocol\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial","ALL","18 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.",[28],"HER2 Expressing Solid Tumors",[30,31,32,33],"HER2+ breast cancer","HER2+ gastric cancer","Other HER+ cancer","HER2-low cancer","RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2025-11-18",{"date":42,"type":21},"2033-10",{"name":44,"class":45},"Vironexis Biotherapeutics Inc.","INDUSTRY",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":74,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":57,"type":21},32,[24,25],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[61,62,63,64,65,66,67,68,69,70,71,72,73],"B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Burkitt Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[75,76,77],"CD19-positive","Leukemia","Lymphoma","2026-03-24",{"date":80,"type":38},"2026-03-30",{"date":82,"type":38},"2025-05-30",{"date":84,"type":21},"2031-09",{"name":44,"class":45},9,""]