[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624504":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":35,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":35,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":97,"overallStatus":45,"whyStopped":35,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Essen Biotech","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Target Antigen-Selected CAR-NK","EXPERIMENTAL","Participants whose profiling identifies one dominant actionable antigen.",[13],"Biological: EB-SELECT Single-Target CAR-NK Cells",{"label":15,"type":10,"description":16,"interventionNames":17},"Dual-Target Antigen-Selected CAR-NK","Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity.",[18],"Biological: Dual-Target Antigen-Selected CAR-NK",[20,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","EB-SELECT Single-Target CAR-NK Cells","Donor-derived CAR-NK cells expressing a single CAR selected from the target menu. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion. Similar conditioning drugs are used in CAR-NK solid tumor trials.",[9],[26,27,28,29],"Lymphodepleting Chemotherapy","Fludarabine","Cyclophosphamide","IL-2",{"type":21,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"Participants whose profiling identifies two actionable antigens, or strong evidence of antigen heterogeneity. WITH Fludarabine (IV) + Cyclophosphamide (IV), administered prior to CAR-NK infusion . Similar conditioning drugs are used in CAR-NK solid tumor trials.",[15],[34,27,28,29],"EB-SELECT Dual-Target CAR-NK Cells",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Rhoda M Smith, PHD","CONTACT","+12077706670","clinical-trials@essen-biotech.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"District One Hospital","RECRUITING","Beijing","Beijing Municipality","086-373","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":35,"email":61},"SAMI XI, MD","+14012275001","SFM@districtonehospital.com",{"type":63,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100624504","phase-1-biomarker-guided-allogeneic-single-target-or-dual-target-car-nk-cell-therapy-for-advanced-solid-tumors-100624504",false,"NCT07410494","Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and\u002For Liquid Biopsy Profiling in Participants With Relapsed\u002FRefractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","SELECT-CAR-NK","Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumor that is relapsed\u002Frefractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and\u002For liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets \"positive\" threshold\n* Arm B: ≥2 antigens meet \"positive\" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV\u002FHCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.","ALL","8 Years","85 Years",{"count":76,"type":77},85,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and\u002For liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.",[84,85,86,87,88,89,90,91,92,93,94,95,96],"Cancer","Breast Cancer","Non-Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (Locally Advanced or Metastatic)","Prostate Cancer - Recurrent","Pancreatic Ductal Adenocarcinoma (PDAC)","Ovarian Cancer","Glioblastoma","Melanoma (Skin Cancer)","Acute Myeloid Leukemia (AML)","Non Hodgkin Lymphoma","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Liver Cancer",[98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114],"CAR-NK","Solid tumor","Dual-target CAR","ctDNA","CAR-T","Breast cancer","Non-small cell lung cancer (NSCLC)","Colorectal cancer (CRC)","Prostate cancer","Pancreatic ductal adenocarcinoma (PDAC)","Ovarian, fallopian tube, and primary peritoneal cancers","Glioblastoma and other high-grade gliomas","Melanoma","Acute myeloid leukemia (AML)","Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma","Multiple myeloma (especially relapsed\u002Frefractory)","Liver cancer (hepatocellular carcinoma, HCC)","2026-02-14",{"date":117,"type":118},"2026-02-18","ACTUAL",{"date":120,"type":118},"2026-02-01",{"date":122,"type":77},"2028-12-28",{"name":5,"class":6},1]