[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444150":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":55,"collaborators":57,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":20,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":88,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Chembrain LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Patients receive EGFRvIII -CAR T cells intracerebroventricular over 15 minutes on day 1. Patients may receive additional cycles based on the persistence of the cells.",[13],"Biological: EGFRvIII-specific hinge-optimized CD3 ζ-stimulatory\u002F41BB-co-stimulatory Chimeric Antigen Receptor autologous T-lymphocytes",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","EGFRvIII-specific hinge-optimized CD3 ζ-stimulatory\u002F41BB-co-stimulatory Chimeric Antigen Receptor autologous T-lymphocytes","ICV administration",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kai Reinikainen, MD\u002FPhD","PRINCIPAL_INVESTIGATOR",[26,37,45],{"facility":27,"status":20,"city":28,"state":20,"zip":20,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":20},"Jyväskylä Central Hospital","Jyväskylä","Finland","FI",{"type":32,"coordinates":33},"Point",[34,35],25.72088,62.24147,{"lat":35,"lon":34},{"facility":38,"status":20,"city":39,"state":20,"zip":20,"country":29,"countryCode":30,"cosmosGeoPoint":40,"geoPoint":44,"contacts":20},"University Of Oulu","Oulu",{"type":32,"coordinates":41},[42,43],25.46816,65.01236,{"lat":43,"lon":42},{"facility":46,"status":20,"city":47,"state":20,"zip":20,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":54,"contacts":20},"Apollo Hospital","New Delhi","India","IN",{"type":32,"coordinates":51},[52,53],77.2148,28.62137,{"lat":53,"lon":52},{"type":56,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[58,61,62],{"name":59,"class":60},"University of Oulu","OTHER",{"name":27,"class":60},{"name":63,"class":60},"Apollo Hospital, New Delhi, India","100444150","phase-1-the-efficacy-and-safety-of-brain-targeting-immune-cells-egfrviii-car-t-cells-in-treating-patients-with-leptomeningeal-disease-from-glioblastoma-administering-patients-egfrviii--car-t-cells-may-help-to-recognize-and-destroy-brain-tumor-cells-in-patients-100444150",false,"NCT05063682","The Efficacy and Safety of Brain-targeting Immune Cells (EGFRvIII-CAR T Cells) in Treating Patients With Leptomeningeal Disease From Glioblastoma. Administering Patients EGFRvIII -CAR T Cells May Help to Recognize and Destroy Brain Tumor Cells in Patients","A Phase 1 Study to Evaluate EGFRvIII -Targeted Chimeric Antigen Receptor (CAR) T Cells for Adult Patients With Leptomeningeal Glioblastoma","CARTREMENDOUS","Inclusion Criteria:\n\n* Participant has been treated for leptomeningeal metastases after intrathecal chemotherapy and\u002For radiation OR refuses to undergo additional radiation and\u002For intrathecal chemotherapy\n* Participant must have a Karnofsky performance status (KPS) \\>= 60\n* Participant must have a life expectancy of \\>= 2 months\n* Women of child-bearing potential must have negative serum pregnancy test and agree to use a reliable form of birth control prior to study entry and for at least two months following study treatment. Male research participants must agree to use a reliable form of birth control and not donate sperm during the study and for at least two months following study treatment\n* Participant has a histologically confirmed EGFRvII+ (epidermal growth factor receptor) tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score \\>= 50)\n* Participant or legal guardian must have the ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Research participant requires supplemental oxygen to keep saturation greater than 95%\n* Research participant requires dialysis\n* Research participant has uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy\n* Failure of research participant or legal guardian to understand the basic elements of the protocol and\u002For the risks\u002Fbenefits of participating in the study.\n* Participant is unwilling to stop treatment with chemotherapy or endocrine therapy and\u002For radiation one week prior and during the first 4 cycles of the study\n* Participant has ventriculoperitoneal shunt\n* Participant has a coagulopathy or bleeding disorder\n* Participant is HIV+ (human immunodeficiency virus) or has acute CMV (cytomegalovirus) infection\n* Participant has any uncontrolled illness, including ongoing or active infection; participant has known active hepatitis B or C infection; participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections\n* Participant has an autoimmune disease that requires constant treatment\n* Participant has another active malignancy\n* Participant is unable to undergo a brain magnetic resonance imaging (MRI)\n* Participant is pregnant or breast feeding","ALL","18 Years",{"count":75,"type":76},10,"ACTUAL","INTERVENTIONAL",[79],"PHASE1","This phase I trial investigates the efficacy and safety of brain-targeting epidermal growth factor receptor chimeric antigen receptor immune cells (EGFRvIII-CAR T cells) in treating patients with leptomeningeal disease from glioblastoma. T cells are part of the immune system and help the body fight malignant tumours. Immune cells can be genetically modified to destroy brain tumor cells in the laboratory. EGFRvIII -CAR T cells are brain tumor specific and can enter and express its genes in immune cells. Administering patients EGFRvIII -CAR T cells may help to recognize and destroy brain tumor cells in patients with leptomeningeal disease from glioblastoma.",[82,83,84],"Glioblastoma","Glioblastoma Multiforme","Glioma, Malignant",[82,86,87],"CAR-T","EGFRvIII","UNKNOWN","2021-09-30",{"date":91,"type":76},"2021-10-01",{"date":93,"type":76},"2020-05-15",{"date":95,"type":96},"2023-10","ESTIMATED",{"name":5,"class":6},3]