[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenocarcinoma-of-colon\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenocarcinoma-of-colon":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"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":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28],"Colorectal Cancer Metastatic","Adenocarcinoma of Colon",[30,31,32,33,34,35,36,37,38,39,40],"CAR-NK","Dual-target CAR","CEACAM5","CEA","GUCY2C","GCC","HER2","ERBB2","Solid tumor immunotherapy","Allogeneic NK cells","Adoptive cell therapy","RECRUITING","2026-03-08",{"date":44,"type":45},"2026-03-10","ACTUAL",{"date":47,"type":45},"2026-02-01",{"date":49,"type":20},"2028-12-22",{"name":51,"class":52},"Beijing Biotech","INDUSTRY",""]