[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611947":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":39,"collaborators":20,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Concurrent and adjuvant allogeneic NK cell therapy","EXPERIMENTAL","Participants will receive standard chemoradiotherapy for locally advanced nasopharyngeal carcinoma along with adjuvant therapy of NK cells. Nk cells would be enriched and expanded using PBMCs from healthy donors.\n\nPhase 1 dose escalation study which uses 5 different dosages of 0.5 x 10\\^7, 0.8x10\\^7, 1.1x10\\^7, 1.4 x 10\\^7, and 1.8x10\\^7 to determine the Maximum tolerated dose (MTD). If the MTD is determined in phase 1, the study will enter phase 2, where the determined dose level will be used for participants. The participants will receive six intravenous NK cell infusions at weeks 3,6,7,8,9, and 10 during and after CRT. If the participant's EBV level is still detectable, they would be suggested for supplementary NK cell treatments for an additional four weeks.",[13],"Biological: Allogenic expanded Natural Killer Cells (AlloNK1)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Allogenic expanded Natural Killer Cells (AlloNK1)","The NK cells would be enriched and expanded ex vivo in a GMP facility from healthy donor PBMCs. Prior to administration, the NK cells would be formulated in an infusion medium based on the corresponding dose level that is required for each participant.\n\nParticipants will receive an intravenous infusion of NK cells during and after the standard CRT. Six doses are administered at weeks 3,6,7,8,9, and 10. In Phase 1, NK cell doses range from 0.5x10\\^7 to 1.8x10\\^7 cells\u002Fkg for the determination of the maximum tolerated dose (MTD). In phase 2, all participants will receive NK cells at the established MTD.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lim Chwee Ming","CONTACT","+65 63265978","lim.chwee.ming@singhealth.com.sg",[28],{"facility":5,"status":20,"city":29,"state":20,"zip":20,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Singapore","SG",{"type":32,"coordinates":33},"Point",[34,35],103.85007,1.28967,{"lat":35,"lon":34},[38],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":40,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100611947","phase-1-integrating-allogeneic-nk-cells-in-high-risk-advanced-stage-iii-iv-nasopharyngeal-cancer-patients-100611947",false,"NCT07247201","Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients","Phase 1\u002F2 Trial Integrating Allogeneic NK Cells in High-risk Advanced Stage III-IV Nasopharyngeal Cancer Patients","AlloNK1","Inclusion Criteria:\n\n* Diagnosed with NPC Stage III-IVA\u002FB (T1-4, N1-3, M0)\n* Able to tolerate convectional CRT\n* Detectable EBV level at diagnosis\n* Adequate organ function ANC ≥ 1500\u002FµL Platelet count ≥ 100,000\u002FµL Creatinine clearance ≥60ml\u002Fminute Total bilirubin ≤ 1.5 x upper limit normal (ULN) AST ≤ 2 x upper limit normal ALT ≤ 2 x upper limit normal\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* History of Autoimmune Disease or any condition resulting in immunocompromised state (e.g., Drug induced)\n* ECOG performance status above or equal to 2\n* Poor Organ Function\n* Lactating or pregnant\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study.","ALL","21 Years","80 Years",{"count":53,"type":54},31,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE1","PHASE2","This clinical trial aims to determine whether Natural Killer (NK) cell therapy administered in combination with concurrent chemoradiotherapy (CRT) can reduce recurrence in patients with advanced nasopharyngeal cancer (NPC), and to identify the highest safe and tolerable dose of allogeneic NK cells. Allogeneic NK cells, derived from healthy donors, have demonstrated good tolerability in cancer patients.\n\nThe primary research questions are:\n\n1. What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients?\n2. Can the addition of allogeneic NK cells to standard CRT reduce the proportion of NPC patients with detectable plasma EBV-DNA from 30% to 10%?\n\nPhase 1: Participants will receive one of five escalating doses of allogeneic NK cells with CRT to determine the MTD.\n\nPhase 2: Participants will receive the established MTD NK dose together with CRT.\n\nParticipants will undergo regular safety monitoring, side-effect assessment, measurement of plasma EBV-DNA levels, and surveillance for disease recurrence.",[61,62,63,64],"Nasopharyngeal Carcinoma (NPC)","Minimal Residual Disease","Recurrent Nasopharyngeal Carcinoma","Maximum Tolerated Dose",[66,67,68,64],"Advanced Nasopharyngeal Cancer","Epstein-Barr Virus DNA","Allogeneic NK Cells","NOT_YET_RECRUITING","2026-03-24",{"date":72,"type":73},"2026-03-30","ACTUAL",{"date":75,"type":54},"2026-04",{"date":77,"type":54},"2026-09",{"name":5,"class":6},1]