[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624518":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":23,"locations":29,"responsibleParty":49,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":11,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":84,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Essen Biotech","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EBNK-001 + IL-15 + Pembrolizumab","EXPERIMENTAL",null,[13],"Biological: EBNK-001 + IL-15 + Pembrolizumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","Biological: EBNK-001 (Allogeneic NK Cells) Dose levels (example): 1×10\\^8; 3×10\\^8; 9×10\\^8 viable cells\u002Finfusion Schedule: weekly infusions on Days 1, 8, and 15 (per cycle)\n\nDrug: Cyclophosphamide (CY) lymphodepletion: 300 mg\u002Fm² IV daily ×2 days (Cycle 1 only) Drug: Fludarabine (FLU)\n\nExample lymphodepletion: 25 mg\u002Fm² IV daily ×2 days (Cycle 1 only) Drug: Interleukin-15 (IL-15) Low-dose IL-15 given after NK cell infusion to support NK cell survival dose used in NK protocols: 6 MIU per dose\n\nDrug: Pembrolizumab Pembrolizumab administered per standard prescribing schedule",[9],[20,21,22],"Pembrolizumab","IL-15","EBNK-001",[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Rhoda M Smith, Phd","CONTACT","2077706670","clinical-trials@essen-biotech.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"District One Hospital","RECRUITING","Beijing","Beijing Municipality","086-373","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":47,"phoneExt":11,"email":48},"SAMI XI, dr","+14012275001","SFM@districtonehospital.com",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624518","phase-1-ebnk-001-allogeneic-nk-cells-with-low-dose-il-15--pembrolizumab-in-advanced-solid-tumors-100624518",false,"NCT07410676","EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors","An Open-Label Phase 1\u002F2 Study of EBNK-001, an Allogeneic Natural Killer (NK) Cell Therapy Administered After Cyclophosphamide\u002FFludarabine Lymphodepletion With Low-Dose Interleukin-15, With or Without Pembrolizumab, in Participants With Advanced Solid Tumors","EBNK-ST-001","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed advanced\u002Fmetastatic solid tumor that is relapsed\u002Frefractory after standard therapy (or no standard therapy available).\n* Measurable disease per RECIST v1.1 (or iRECIST if applicable).\n* ECOG performance status 0-1 (or 0-2 as allowed).\n* Adequate organ function (thresholds modeled on NK protocols):\n* Platelets ≥ 75,000\u002FµL; hemoglobin ≥ 9 g\u002FdL; ANC ≥ 1,000\u002FµL (unsupported by growth factors\u002Ftransfusions as defined).\n* eGFR ≥ 60 mL\u002Fmin\u002F1.73m².\n* AST\u002FALT ≤ 3× ULN.\n* Oxygen saturation ≥ 90% on room air (with PFT requirements if indicated).\n* LVEF ≥ 40% (by ECHO\u002FMUGA\u002FCMR).\n* If brain metastases are present, they must be stable for a defined period (example: ≥3 months) and not requiring escalating steroids.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Any condition requiring systemic immunosuppression (e.g., \\>5 mg prednisone\u002Fday or equivalent) during dosing window (topical\u002Finhaled may be allowed).\n* Active autoimmune disease requiring systemic immunosuppression.\n* Uncontrolled bacterial, fungal, or viral infection.\n* Receipt of investigational agent within 28 days before first study drug.\n* Live vaccine within 6 weeks prior to lymphodepletion.\n* Known HIV positivity or active hepatitis B\u002FC with detectable viral load (protocol may allow chronic asymptomatic hepatitis depending on risk plan).\n* Known allergy to investigational product components (example: albumin\u002Fhuman or DMSO).\n* Any medical\u002Fsocial condition likely to interfere with study compliance or increase risk.","ALL",{"count":61,"type":62},83,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","This Phase 1\u002F2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide\u002Ffludarabine (CY\u002FFLU) and supported with low-dose IL-15, administered either alone or in combination with pembrolizumab in adults with advanced\u002Fmetastatic solid tumors. The study will determine a recommended Phase 2 dose (RP2D) and explore signals of clinical activity using RECIST-based response criteria.",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Cancer","Sarcoma","Leukaemia","Breast Cancer (Locally Advanced or Metastatic)","Lung Cancer (Diagnosis)","Colorectal Cancer","Melanoma (Skin Cancer)","Bladder Cancer","Kidney Cancer","Pancreatic Cancer Metastatic","Liver Cancer (Primary and Metastatic)","Ovarian Cancer","Esophageal Cancer","Glioblastoma","Non-Melanoma Skin Cancer",[85,86,87,21,88,89,90,91,92,83,93,76,94,95,96,81],"Natural killer cells","NK cell therapy","Solid tumors","Breast Cancer","Lung and Bronchus Cancer","Prostate Cancer","Colorectal (Colon and Rectal) Cancer","CAR-T","Melanoma","Kidney (Renal Cell and Renal Pelvis) Cancer","Pancreatic Cancer","Stomach (Gastric) Cancer","2026-02-14",{"date":99,"type":100},"2026-02-18","ACTUAL",{"date":102,"type":100},"2026-02-01",{"date":104,"type":62},"2029-12-21",{"name":5,"class":6},1]