[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462233":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":40,"responsibleParty":63,"collaborators":28,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":28,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":28,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Bambino Gesù Hospital and Research Institute","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM A: MB\u002Fother embryonal tumor","EXPERIMENTAL","After a lymphodepleting regimen, patients affected by relapsed\u002Frefractory MB\u002Fother embryonal tumor will receive 1.0 to 6.0 x 10⁶\u002Fkg GD2 Chimeric Antigen Receptor (CAR) positive T cells.",[13],"Biological: GD2-CART01 (iC9-GD2-CAR T-cells)",{"label":15,"type":10,"description":16,"interventionNames":17},"ARM B: Hemispheric HGG","After a lymphodepleting regimen, patients affected by relapsed\u002Frefractory hemispheric high grade glioma will receive 1.0 to 6.0 x 10⁶\u002Fkg GD2 Chimeric Antigen Receptor (CAR) positive T cells.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"ARM C: Thalamic HGG, DMG, DIPG and other rare CNS tumors not included in Arm A and B","After a lymphodepleting regimen, patients affected by relapsed\u002Frefractory thalamic HGG, DMG, DIPG and other rare CNS tumors not included in Arm A and B will receive 1.0 to 6.0 x 10⁶\u002Fkg GD2 Chimeric Antigen Receptor (CAR) positive T cells.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","GD2-CART01 (iC9-GD2-CAR T-cells)","Following a lymphodepleting treatment with conventional chemotherapy, patients will be treated with 1.0 to 6.0 x 10⁶\u002Fkg GD2 Chimeric Antigen Receptor (CAR) positive T cells, infused i.v. as a single dose",[9,15,19],null,[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Francesca Del Bufalo, MD","CONTACT","00396859","2739","francesca.delbufalo@opbg.net",{"name":37,"role":32,"phone":33,"phoneExt":38,"email":39},"Angela Mastronuzzi, MD, PhD","4647","angela.mastronuzzi@opbg.net",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Ospedale Pediatrico Bambino Gesù","RECRUITING","Roma","Italy","00165","IT",{"type":49,"coordinates":50},"Point",[51,52],11.10642,44.99364,{"lat":52,"lon":51},[55,58,60],{"name":56,"role":32,"phone":57,"phoneExt":34,"email":35},"Francesca del Bufalo, MD PhD","0039-066859",{"name":59,"role":32,"phone":57,"phoneExt":38,"email":39},"Angela Mastronuzzi, MD PhD",{"name":61,"role":62,"phone":28,"phoneExt":28,"email":28},"Franco Locatelli, MD PhD","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Franco Locatelli","Head of the Department of Pediatric Hematology\u002FOncology and Cell and Gene Therapy","100462233","phase-1-gd2-car-t-cells-for-pediatric-brain-tumours-100462233",false,"NCT05298995","GD2-CAR T Cells for Pediatric Brain Tumours","Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed\u002FRefractory Central Nervous System Tumors","Inclusion Criteria:\n\n1. Imaging assessments performed within 14 days of start of treatment\n2. Age: 6months-30years\n3. Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment\n4. Karnofsky\u002FLansky≥60\n5. Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated thrombocytopenia), patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria\n6. Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB, Stockholm Sweden)\n7. Written and signed informed consent from patients, parents or legal guardians. For subjects \\\u003C 18 year-old their legal guardian must give informed consent. In addition, pediatric subjects will be included in age-appropriate discussion and written informed assent will be obtained for those greater than or equal to 7 years of age, when appropriate\n8. Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n9. Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe,uncontrolledactiveinfections\n3. HIV or active HCV and\u002For HBV infection\n4. Rapidly progressive disease with life expectancy \\\u003C 6 weeks\n5. Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts\n6. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN based on age and laboratory specific normal ranges\n7. Renal function: serum creatinine \\> 3x ULN for age\n8. Blood oxygen saturation \\\u003C 90%\n9. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO\n10. Marrow function: absolute neutrophils count (ANC) lower than 500\u002Fmm3 and\u002For platelets lower than 20.000 (not reached by transfusion)\n11. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:\n\n    1. If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\n    2. Systemic chemotherapy in the 3 weeks preceding infusion\n    3. Immunosuppressive agents less than or equal to 30 days\n    4. Radiation therapy must have been completed at least 6 weeks prior to enrollment\n    5. Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy\n\n13.Patient-derived GD2-CART01 production failure: vitality \\\u003C80%, CD3+ cells \\\u003C80%, CD3+ CAR+ cells \\\u003C20%, CD3+ CAR+ antitumor activity \\\u003C60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \\>20%, RCR positivity, Vector Copy Number \\>10, non-sterility, endotoxin contamination (\\> 1 EU\u002Fml)","ALL","6 Months","30 Years",{"count":77,"type":78},54,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed\u002Frefractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.",[84,85,86,87,88,89,90],"Brain Tumor, Pediatric","Medulloblastoma, Childhood","Embryonal Tumor","High Grade Glioma","Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma","Brain Tumor Adult",[92,93,94,88,89,95,96,97,98,99],"Brain tumors","high grade glioma","medulloblastoma","CAR T cell","GD2-antigen","Immunotherapy","Pediatric Central Nervous System tumours","Central nervous system tumour young adults","2025-02-03",{"date":102,"type":103},"2025-02-05","ACTUAL",{"date":105,"type":103},"2023-11-09",{"date":107,"type":78},"2038-11",{"name":5,"class":6},1]