[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628516":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":55,"collaborators":28,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":28,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":28,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"CEA+GUCY2C Dual CAR-NK","EXPERIMENTAL","CRC with tumor co-expression of CEA (CEACAM5) and GUCY2C (GCC) above prespecified thresholds.",[13],"Biological: EB-DUO-CAR-NK-CEA\u002FGCC (IV)",{"label":15,"type":10,"description":16,"interventionNames":17},"CEA+HER2 Dual CAR-NK","CRC with CEA expression and HER2\u002FERBB2 positivity (HER2 criteria per CRC testing guidance).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"GUCY2C+HER2 Dual CAR-NK","CRC with GUCY2C expression and HER2\u002FERBB2 positivity (subset).",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","EB-DUO-CAR-NK-CEA\u002FGCC (IV)","Allogeneic dual-target CAR-NK cells manufactured from cord blood-derived NK cells, genetically engineered to express a tandem (dual-binding) CAR, an IL-15 support element (e.g., membrane-bound IL-15 or IL-15\u002FIL-15R fusion), and an inducible suicide switch",[9,15,19],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":45,"coordinates":46},"Point",[47,48],114.0683,22.54554,{"lat":48,"lon":47},[51],{"name":52,"role":32,"phone":53,"phoneExt":28,"email":54},"Zhen J Peng, Phd","+8613076790039","Zhen-Peng@beijing-biotech.com",{"type":56,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100628516","phase-1-dual-target-car-nk-cells-for-biomarker-selected-advanced-colorectal-cancer-100628516",false,"NCT07462650","Dual-Target CAR-NK Cells for Biomarker-Selected Advanced Colorectal Cancer","A Phase 1\u002F2, Biomarker-Assigned, Open-Label Dose Escalation and Expansion Study of Allogeneic Dual-Target CAR-NK Cells Targeting CEA (CEACAM5) and\u002For GUCY2C (GCC) With an Exploratory HER2\u002FERBB2-Positive Cohort in Subjects With Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.\n* Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).\n* Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.\n* ECOG performance status 0-1.\n* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.\n* Recovered to Grade \\\u003C=1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).\n* Life expectancy \\>= 12 weeks.\n* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.\n\nExclusion Criteria:\n\n* Active, uncontrolled infection (including uncontrolled HBV\u002FHCV) or known uncontrolled HIV infection.\n* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)\n* Prior gene-modified cellular therapy (CAR-T\u002FCAR-NK\u002FTCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.\n* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.\n* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.\n* Pregnant or breastfeeding.\n* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.\n* Known hypersensitivity to study chemotherapy components (fludarabine\u002Fcyclophosphamide) or required supportive medications.\n* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.","ALL","18 Years","75 Years",{"count":68,"type":69},48,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy\u002Fbiomarker signals) will be selected for dose expansion.",[76,77],"Colorectal Cancer Metastatic","Adenocarcinoma of Colon",[79,80,81,82,83,84,85,86,87,88,89],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","HER2","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","2026-03-08",{"date":92,"type":93},"2026-03-10","ACTUAL",{"date":95,"type":93},"2026-02-01",{"date":97,"type":69},"2028-12-22",{"name":5,"class":6},1]