[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631561":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":36,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":36,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EB-DTNB-NK","EXPERIMENTAL","Participants receive protocol-defined fludarabine\u002Fcyclophosphamide lymphodepletion followed by intravenous allogeneic dual-target GD2\u002FB7-H3 CAR-NK cells on Day 0 at the assigned dose level or RP2D. Additional doses on Days 7 and 14 are permitted if predefined safety criteria are met and there is no prohibitive toxicity or rapid progression.",[13,14,15],"Biological: EB-DTNB-NK","Drug: Fludarabine","Drug: Cyclophosphamide",[17,23,30],{"type":18,"name":9,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Allogeneic, cord blood-derived NK cells engineered with a dual-target CAR recognizing GD2 and B7-H3 (CD276), with IL-15 support and an inducible safety switch; administered intravenously on Day 0 with optional repeat dosing on Days 7 and 14 if tolerated.",[9],[22],"Dual-target GD2\u002FB7-H3 CAR-NK",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Fludarabine","Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-defined conditioning regimen.",[9],[29],"Flu",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Cyclophosphamide","Lymphodepleting chemotherapy administered before CAR-NK infusion according to the protocol-definedb conditioning regimen.",[9],[35],"Cy",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":53,"coordinates":54},"Point",[55,56],114.0683,22.54554,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":36,"email":62},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":64,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100631561","phase-1-dual-target-gd2b7-h3-car-nk-cells-for-pediatric-relapsed-or-refractory-neuroblastoma-100631561",false,"NCT07502287","Dual-Target GD2\u002FB7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma","A Phase 1\u002FPhase 2, Open-Label Study of BiomarkerInformed, Allogeneic Dual-Target GD2\u002FB7-H3 (CD276) CAR-NK Cells in Children and Young Adults With Relapsed or Refractory Neuroblastoma","DUAL-NK-NB","Inclusion Criteria:\n\n* Age 12 months to 21 years at consent\u002Fassent.\n* Histologically confirmed neuroblastoma or ganglioneuroblastoma with relapsed, refractory, progressive, or persistent high-risk disease for which no curative standard option is available.\n* Measurable or evaluable disease according to revised International Neuroblastoma Response Criteria (rINRC), including MIBG-avid disease, CT\u002FMRI-evaluable soft-tissue disease, and\u002For bone marrow disease.\n* Tumor material available for central assessment of GD2 and B7-H3 expression; at least one target must be positive.\n\nGD2 is treated as the core target and B7-H3 as the complementary target for correlative target-prioritization analyses.\n\n* Prior exposure to standard neuroblastoma therapy, including anti-GD2-based therapy, unless contraindicated, unavailable, or declined for a documented medical reason.\n* Lansky or Karnofsky performance score \\>= 50.\n* Life expectancy \\>= 8 weeks.\n* Recovery from clinically significant acute toxicities of prior therapy and protocol-defined washout from chemotherapy, biologics, radiation, and prior cell therapy.\n* Adequate organ function: hematologic, renal, hepatic, cardiac, and pulmonary function considered sufficient by protocoldefined laboratory and clinical thresholds.\n* Negative pregnancy test for patients of childbearing potential and agreement to use effective contraception during the protocol-defined period.\n* Written informed consent from parent\u002Flegal guardian and assent from the participant when appropriate.\n\nExclusion Criteria:\n\n* Active uncontrolled infection, including bacteremia, uncontrolled viral infection, or invasive fungal disease.\n* Pregnancy or breastfeeding.\n* Active grade \\>= 2 graft-versus-host disease, or systemic immunosuppression for treatment\u002Fprevention of graft-versushost disease within the protocol-defined washout period after prior allogeneic transplant.\n* Symptomatic or unstable central nervous system disease requiring urgent medical intervention.\n* Prior genetically modified cellular therapy within the protocol-defined washout window, or unresolved clinically significant toxicity from prior cell therapy.\n* Active autoimmune disease requiring systemic immunosuppressive therapy.\n* Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, or neurologic disorder that would increase study risk.\n* Known hypersensitivity to fludarabine, cyclophosphamide, study-product components, or supportive-care medications required by the protocol.\n* Known uncontrolled HIV infection or uncontrolled hepatitis B or C.\n* Any medical, psychosocial, or logistical condition that, in the investigator's judgment, would make study participation unsafe or would impair protocol adherence.","ALL","12 Months","21 Years",{"count":77,"type":78},36,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","This illustrative Phase 1\u002FPhase 2 study tests allogeneic dual-target GD2\u002FB7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma. After lymphodepletion, participants receive IV CAR-NK cells;Part A defines the RP2D and Part B estimates preliminary activity",[85,86,87,88],"Relapsed Neuroblastoma","Refractory Neuroblastoma","High-Risk Neuroblastoma","Ganglioneuroblastoma",[90,91,92,93,94,95,96,97,98,99,100],"pediatric neuroblastoma","CAR-NK","GD2","B7-H3","CD276","dual-targeting","relapsed\u002Frefractory","allogeneic","solid tumor immunotherapy","cell therapy","biomarkerinformed design","2026-03-25",{"date":103,"type":104},"2026-03-30","ACTUAL",{"date":106,"type":104},"2026-03-02",{"date":108,"type":78},"2028-06-17",{"name":5,"class":6},1]