[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629920":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":42,"locations":48,"responsibleParty":67,"collaborators":30,"id":69,"slug":30,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"IL13Rα2 + EGFR\u002FEGFRvIII Dual-Target CAR-NK","EXPERIMENTAL","Participants whose tumors meet eligibility thresholds for IL13Rα2 and EGFR (and\u002For EGFRvIII) will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and EGFR\u002FEGFRvIII.",[13,14,15,16],"Biological: Dual-target CAR-NK cells","Drug: Cyclophosphamide","Drug: Fludarabine","Device: Intracranial catheter\u002Freservoir for locoregional delivery",{"label":18,"type":10,"description":19,"interventionNames":20},"IL13Rα2 + B7-H3 (CD276) Dual-Target CAR-NK","Participants whose tumors meet eligibility thresholds for IL13Rα2 and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and B7-H3.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"EGFR\u002FEGFRvIII + B7-H3 (CD276) Dual-Target CAR-NK","Participants whose tumors meet eligibility thresholds for EGFR (and\u002For EGFRvIII) and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing EGFR\u002FEGFRvIII and B7-H3.",[13,14,15,16],[26,31,35,38],{"type":27,"name":28,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Dual-target CAR-NK cells",[22,18,9],null,{"type":32,"name":33,"description":33,"armGroupLabels":34,"otherNames":30},"DRUG","Cyclophosphamide",[22,18,9],{"type":32,"name":36,"description":36,"armGroupLabels":37,"otherNames":30},"Fludarabine",[22,18,9],{"type":39,"name":40,"description":40,"armGroupLabels":41,"otherNames":30},"DEVICE","Intracranial catheter\u002Freservoir for locoregional delivery",[22,18,9],[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China",{"type":57,"coordinates":58},"Point",[59,60],114.0683,22.54554,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":30,"email":66},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":68,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100629920",false,"NCT07480941","Dual-Targeting CAR-NK Cells for Recurrent\u002FProgressive Glioblastoma and High-Grade Glioma","A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR\u002FEGFRvIII, and\u002For B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma","DUAL-CAR-NK-GB","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.\n* Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.\n* Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rα2, EGFR (wild-type) and\u002For EGFRvIII, B7-H3 (CD276).\n* Karnofsky Performance Status (KPS) ≥ 60.\n* Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.\n* Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).\n* Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.\n* Ability to understand and willingness to sign informed consent.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).\n* Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Requirement for high-dose systemic corticosteroids (e.g., \\>4 mg\u002Fday dexamethasone equivalent) within 7 days prior to lymphodepletion\u002Finfusion (physiologic replacement permitted).\n* Prior gene-modified cellular therapy (e.g., prior CAR-T\u002FCAR-NK) within 6 months, or prior therapy targeting IL13Rα2, EGFR\u002FEGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.\n* Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).\n* Uncontrolled seizures despite optimal medical therapy.\n* Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.\n* Pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.","ALL","18 Years","75 Years",{"count":80,"type":81},36,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR\u002FEGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.",[87,88,89,90,91],"Glioblastoma","High-grade Glioma","Malignant Glioma","Recurrent Glioblastoma","Recurrent High-grade Glioma",[93,94,95,96,97,98,99,100,101,102,103],"CAR-NK","dual targeting","IL13Rα2","EGFR","EGFRvIII","B7-H3","CD276","locoregional","intracavitary","Ommaya reservoir","biomarker-guided","2026-03-14",{"date":106,"type":107},"2026-03-18","ACTUAL",{"date":109,"type":107},"2026-02-02",{"date":111,"type":81},"2028-03-17",{"name":5,"class":6},1]