[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637258":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":22,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":22,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EGFR\u002FHER2 Dual-Target CAR-NK After Flu\u002FCy","EXPERIMENTAL","Participants receive fludarabine and cyclophosphamide lymphodepletion on Days -5 to -3, followed by EGFR\u002FHER2 dual-target CAR-NK cell infusions on Days 0, 7, and 14. A second cycle may be allowed after Day 28 in selected participants with ongoing benefit and acceptable toxicity.",[13,14,15],"Biological: EGFR\u002FHER2 Dual-Target CAR-NK Cells","Drug: Fludarabine","Drug: Cyclophosphamide",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","EGFR\u002FHER2 Dual-Target CAR-NK Cells","Allogeneic donor-derived activated \u002Fexpanded NK cells engineered to express a dual EGFR\u002FHER2 chimeric antigen receptor, membrane-bound IL-15, and an inducible caspase-9 safety switch",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Fludarabine","Lymphodepleting chemotherapy administered before the first infusion according to protocol-defined dose and schedule.",[9],{"type":24,"name":29,"description":26,"armGroupLabels":30,"otherNames":22},"Cyclophosphamide",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":47,"coordinates":48},"Point",[49,50],114.0683,22.54554,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":22,"email":56},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":58,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100637258","phase-1-egfrher2-dual-target-car-nk-cells-for-recurrent-or-metastatic-hnscc-100637258",false,"NCT07617805","EGFR\u002FHER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC","A Phase 1\u002F2, Open-Label, Biomarker-Enriched Study of Allogeneic EGFR\u002FHER2 Dual-Target CAR-NK Cells Following Fludarabine\u002FCyclophosphamide Lymphodepletion in Adults With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","DUAL-HN","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx that is recurrent or metastatic and not amenable to curative surgery or radiotherapy.\n* Tumor meets protocol-defined central biomarker criteria for both EGFR and HER2 \u002F ERBB2. Suggested example thresholds: EGFR membranous IHC 2+ \u002F 3+ in at least 50% of viable tumor cells and HER2 IHC 2+ \u002F 3+ in at least 10% of viable tumor cells and \u002F or protocol-defined genomic amplification \u002F activating alteration.\n* Disease progression on or after at least one prior systemic regimen for recurrent \u002F metastatic disease, including platinum therapy and PD-1 \u002F PD-L1 inhibitor unless contraindicated or not appropriate. Prior cetuximab is allowed.\n* At least one measurable lesion by RECIST 1.1.\n* ECOG performance status 0 to 1.\n* Adequate marrow, renal, hepatic, cardiac, and pulmonary function per protocol-defined laboratory thresholds.\n* Life expectancy of at least 12 weeks.\n* Availability of archival tissue or willingness to provide fresh tumor tissue for central biomarker testing; willingness to undergo serial blood sampling and optional research biopsy if medically feasible.\n* Negative pregnancy test for participants of childbearing potential and agreement to use highly effective contraception during protocol-defined treatment and follow-up windows.\n* Ability to understand and sign informed consent.\n\nExclusion Criteria:\n\n* Nasopharyngeal carcinoma, salivary gland malignancy, cutaneous squamous cell carcinoma, non-squamous histology, or carcinoma of unknown primary.\n* Untreated, unstable, or symptomatic central nervous system metastases or leptomeningeal disease.\n* Prior gene-modified adoptive cell therapy (for example CAR-T, CAR-NK, or TCR-T) within a protocol-defined washout period, or prior allogeneic stem-cell transplant with active graft-versus-host disease.\n* Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection; active hepatitis B or C with detectable viral load; or uncontrolled HIV infection.\n* Active autoimmune disease requiring systemic immunosuppression, or chronic corticosteroid use above the protocoldefined threshold before lymphodepletion.\n* Clinically significant interstitial lung disease, oxygen dependence, or another serious pulmonary condition that would materially increase cell-therapy risk.\n* Clinically significant cardiovascular disease including recent myocardial infarction, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, or symptomatic heart failure.\n* Major surgery within 28 days before lymphodepletion, or anticancer therapy \u002F investigational therapy within the protocol-defined washout window.\n* Pregnancy or breastfeeding.\n* Known severe hypersensitivity to fludarabine, cyclophosphamide, or cell-product excipients.\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, would compromise safety, protocol compliance, or informed consent.","ALL","18 Years","75 Years",{"count":71,"type":72},42,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","This example Phase 1\u002F2 protocol evaluates allogeneic EGFR\u002FHER2 dual-target CAR-NK cells in adults with recurrent or metastatic HNSCC whose tumors meet protocol-defined co-expression criteria for EGFR and HER2\u002FERBB2. The study is designed as a biomarker-enriched, open-label, non-randomized trial with a dose-escalation safety lead-in followed by an expansion cohort at the recommended Phase 2 dose (RP2D).",[79,80],"Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Biomarker-positive EGFR\u002FHER2- Expressing HNSCC",[82,83,84,85,86,87,88,89,90],"Solid tumor","Head and neck squamous cell carcinoma (HNSCC)","CAR-NK","Adoptive cell therapy","Allogeneic NK cells","Biomarker-enriched","EGFR","HER2","ERBB2","2026-05-25",{"date":93,"type":94},"2026-06-01","ACTUAL",{"date":96,"type":94},"2026-03-02",{"date":98,"type":72},"2028-05-17",{"name":5,"class":6},1]