[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637706":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":35,"locations":41,"responsibleParty":61,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":29,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":44,"whyStopped":29,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: CEA+GUCY2C Dual CAR-NK","EXPERIMENTAL","CRC with tumor co-expression of CEA (CEACAM5) and GUCY2C (GCC) above prespecified thresholds",[13,14],"Biological: EB-DUO-CAR-NK-CEA\u002FGCC","Drug: Lymphodepletion",{"label":16,"type":10,"description":17,"interventionNames":18},"CEA+HER2 Dual CAR-NK","CRC with CEA expression and HER2\u002FERBB2 positivity",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"GUCY2C+HER2 Dual CAR-NK","CRC with GUCY2C expression and HER2\u002FERBB2 positivity",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","EB-DUO-CAR-NK-CEA\u002FGCC","ogeneic 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",[9,16,20],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DRUG","Lymphodepletion","Lymphodepleting chemotherapy ( fludarabine and cyclophosphamide) administered pre-infusion to facilitate CAR-NK cell engraftment.",[9,16,20],[36],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"Seni S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":51,"coordinates":52},"Point",[53,54],114.0683,22.54554,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":29,"email":60},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":62,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100637706","phase-1-dual-targeting-car-nk-cells-in-biomarker-selected-advanced-colorectal-cancer-100637706",false,"NCT07589517","Dual-Targeting CAR-NK Cells in 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","DUO-CRC-NK-111","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 ≤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":75,"type":76},48,"ESTIMATED","INTERVENTIONAL",[79,80],"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.",[83,84,85],"Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","Unresectable Colorectal Cancer",[87,88,89,90,91,92,93,94,95,96,97],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","HER2","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","2026-05-10",{"date":100,"type":101},"2026-05-15","ACTUAL",{"date":103,"type":101},"2026-02-02",{"date":105,"type":76},"2028-03-17",{"name":5,"class":6},1]