[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647145":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":51,"collaborators":32,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":32,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":32,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":32,"overallStatus":72,"whyStopped":32,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Beijing Gene Key Life Technology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GKL-006Allo Injection","EXPERIMENTAL","Natural killer T cells (NKT) are a type of special lymphocyte discovered in recent years that mediate both innate and adaptive immunity, and are considered the fourth type of lymphocyte. GKL-006Allo is an allogeneic iNKT cell.",[13],"Biological: GKL-006Allo Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","GKL-006Allo Injection is an allogeneic invariant natural killer T (iNKT) cell therapy. It will be administered according to the dose level, dosing schedule, and treatment stage specified in the protocol.",[9],[20,21],"Allogeneic iNKT Cell Therapy","Allogeneic invariant natural killer T cell therapy",[23],{"name":24,"affiliation":25,"role":26},"Ning Li, MD","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Cancer Hospital Chinese Academy of Medical Sciences","CONTACT","+86-316-5916013",null,"lining@cisams.ac.cn",[35],{"facility":29,"status":32,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Beijing","Beijing Municipality","100021","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":50,"phoneExt":32,"email":33},"GCP Center","0316-5916013",{"type":52,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100647145","phase-1-gkl-006allo-injection-in-patients-with-advanced-solid-tumors-100647145",false,"NCT07704515","GKL-006Allo Injection in Patients With Advanced Solid Tumors","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006Allo Injection in Patients With Solid Tumors","Inclusion Criteria:\n\n* Able to understand and voluntarily sign the informed consent form.\n* Aged 18 to 75 years.\n* Histologically, cytologically or clinical confirmed unresectable locally advanced or metastatic solid tumor that has failed standard therapy.\n* At least one measurable tumor lesion during screening according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and life expectancy of at least 3 months.\n* Adequate hematologic and organ function.\n* Participants of childbearing potential must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after the end of study treatment.\n* Able to communicate with the investigator, comply with study visits, and understand and follow study requirements.\n\nExclusion Criteria:\n\n* Recently received radical radiotherapy or other anti-tumor therapy.\n* Known hypersensitivity to any component of the study treatment.\n* Prior history or concurrent malignancy that has not been cured.\n* Active infection, known or suspected autoimmune disease.\n* Last anti-tumor treatment toxicity not yet recovered to suitable status.\n* Other organ dysfunction or situations deemed inappropriate by the investigator.","ALL","18 Years","75 Years",{"count":64,"type":65},27,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of GKL-006Allo Injection in participants with advanced solid tumors.",[71],"Solid Tumor Malignancies","NOT_YET_RECRUITING","2026-07-14",{"date":75,"type":76},"2026-07-15","ACTUAL",{"date":78,"type":65},"2026-08-30",{"date":80,"type":65},"2029-01-31",{"name":5,"class":6},1]