[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biomarker-positive-egfrher2--expressing-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biomarker-positive-egfrher2--expressing-hnscc":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25,26],"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).",[29,30],"Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Biomarker-positive EGFR\u002FHER2- Expressing HNSCC",[32,33,34,35,36,37,38,39,40],"Solid tumor","Head and neck squamous cell carcinoma (HNSCC)","CAR-NK","Adoptive cell therapy","Allogeneic NK cells","Biomarker-enriched","EGFR","HER2","ERBB2","RECRUITING","2026-05-25",{"date":44,"type":45},"2026-06-01","ACTUAL",{"date":47,"type":45},"2026-03-02",{"date":49,"type":22},"2028-05-17",{"name":51,"class":52},"Beijing Biotech","INDUSTRY"]