[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634846":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":105,"centralContacts":69,"locations":109,"responsibleParty":129,"collaborators":131,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":69,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":69,"enrollmentInfo":144,"targetDuration":69,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":69,"overallStatus":111,"whyStopped":69,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (EGFR\u002FIL13Rα2 pool-CAR T cell therapy)","EXPERIMENTAL","Patients undergo leukapheresis followed by surgical resection, biopsy, and ICT and\u002For ICV catheter placement 1-3 weeks prior to cycle 1, day 0. Patients then receive EGFR\u002FIL13Rα2 pool-CAR T cells via ICT and\u002For ICV catheter over 5 minutes on day 1 of each cycle. Cycles repeat every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of EGFR\u002FIL13Rα2 pool-CAR T cells per PI and patient discretion and\u002For undergo additional leukapheresis as needed on study. Patients also undergo ECHO during screening, as well as FDG-PET, MRI, and blood, TCF, and CSF sample collection throughout the study.",[13,14,15,16,17,18,19,20,21],"Biological: Autologous Anti-EGFR\u002FAnti-IL13Ralpha2 CAR T-cells","Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Procedure: Echocardiography Test","Procedure: FDG-Positron Emission Tomography","Procedure: Intracranial Catheter Placement","Procedure: Leukapheresis","Procedure: Magnetic Resonance Imaging","Procedure: Resection",[23,33,42,50,57,65,70,79,99],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Autologous Anti-EGFR\u002FAnti-IL13Ralpha2 CAR T-cells","Given via ICT and\u002For ICV catheter",[9],[29,30,31,32],"Autologous Anti-EGFR\u002FAnti-IL13Ra2 CAR T-cells","Autologous Anti-EGFR\u002FIL13Ra2 CAR T Cells","Autologous Anti-EGFR\u002FIL13Ra2 CAR-T Cells","CART-EGFR-IL13Ra2 Cells",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[9],[39,40,41],"Biopsy","BIOPSY_TYPE","Bx",{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Biospecimen Collection","Undergo blood, TCF, and CSF sample collection",[9],[47,48,49],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":34,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Echocardiography Test","Undergo ECHO",[9],[55,56],"EC","Echocardiography",{"type":34,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"FDG-Positron Emission Tomography","Undergo FDG-PET",[9],[62,63,64],"FDG","FDG-PET","FDG-PET Imaging",{"type":34,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Intracranial Catheter Placement","Undergo ICT and\u002For ICV catheter placement",[9],null,{"type":34,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"Leukapheresis","Undergo leukapheresis",[9],[75,76,77,78],"Leukocyte Adsorptive Apheresis","Leukocytopheresis","Therapeutic Leukopheresis","White Blood Cell Reduction Apheresis",{"type":34,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Magnetic Resonance Imaging","Undergo MRI",[9],[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":34,"name":100,"description":101,"armGroupLabels":102,"otherNames":103},"Resection","Undergo surgical resection",[9],[104],"Surgical Resection",[106],{"name":107,"affiliation":5,"role":108},"Behnam Badie","PRINCIPAL_INVESTIGATOR",[110],{"facility":5,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"RECRUITING","Duarte","California","91010","United States","US",{"type":118,"coordinates":119},"Point",[120,121],-117.97729,34.13945,{"lat":121,"lon":120},[124,128],{"name":107,"role":125,"phone":126,"phoneExt":69,"email":127},"CONTACT","626-218-7293","bbadie@coh.org",{"name":107,"role":108,"phone":69,"phoneExt":69,"email":69},{"type":130,"investigatorFullName":69,"investigatorTitle":69,"investigatorAffiliation":69,"oldNameTitle":69,"oldOrganization":69},"SPONSOR",[132],{"name":133,"class":134},"National Cancer Institute (NCI)","NIH","100634846","phase-1-locoregional-administration-of-genetically-engineered-cells-egfril13r2-pool-car-t-cells-for-the-treatment-of-recurrent-or-progressive-high-grade-gliomas-100634846",false,"NCT07544992","Locoregional Administration of Genetically Engineered Cells (EGFR\u002FIL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas","A Phase 1 Trial to Evaluate the Safety of EGFR\u002FIL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Main Inclusion Criteria\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.\n* Age 18 years and older.\n* KPS ≥ 70%, ECOG ≤ 2 (Appendix A).\n* Life expectancy ≥ 4 weeks.\n* Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.\n* COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):\n\n  * IL13Rα2+ expression by IHC \\> 20, and\n  * EGFR gene-altered by NGS or FISH analysis\n* No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.\n* WBC \\> 2000 \u002Fdl (or ANC ≥ 1,000\u002Fmm3)\n* Platelets ≥ 75,000\u002Fmm3\n* Hemoglobin \\> 9g\u002FdL\n* Total bilirubin ≤ 1.5x ULN\n* AST ≤ 2.5x ULN\n* ALT ≤ 2.5x ULN\n* Serum creatinine ≤1.6 mg\u002FdL\n* O2 saturation ≥ 95% on room air.\n* Seronegative for HIV Ag\u002FAb combo, HCV, and active HBV\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.\n\nMain Exclusion Criteria\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.\n* Participant has not yet recovered from toxicities of prior therapy.\n* Participant has received any live vaccine within 30 days prior to enrollment.\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Clinically significant uncontrolled illness.\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.\n* Other active malignancy.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).","ALL","18 Years",{"count":145,"type":146},24,"ESTIMATED","INTERVENTIONAL",[149],"PHASE1","This phase I trial studies the side effects and best dose of EGFR\u002FIL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR\u002FIL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.",[152,153],"Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","2026-06-10",{"date":156,"type":157},"2026-06-12","ACTUAL",{"date":159,"type":146},"2026-12-24",{"date":161,"type":146},"2031-11-04",{"name":5,"class":6},1]