[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531099":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-cancer Neoantigen mRNA Vaccine","EXPERIMENTAL","Anti-cancer neoantigen mRNA vaccine will be produced to treat advanced solid tumors.",[13],"Biological: Neoantigen mRNA Vaccine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Neoantigen mRNA Vaccine","Deliver neoantigen mRNA vaccine into patients for anti-ancer therapy.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Zhenfeng Zhang, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","0086-020-39195965","zhangzhf@gzhmu.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Bingjia He, MD","+862039195965","464677938@qq.com",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Guangzhou","Guangdong","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":50,"phoneExt":20,"email":29},"Zhang Zhenfeng, MD, PhD","+862039195966",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100531099","phase-1-anti-cancer-neoantigen-mrna-vaccine-to-treat-solid-tumors-100531099",false,"NCT06195384","Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors","Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate.","ALL","18 Years","75 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.",[71],"Solid Tumor, Adult",[73,74,75],"mRNA Vaccine","Solid Tumor","Immunotherapy","2024-06-22",{"date":78,"type":79},"2024-06-26","ACTUAL",{"date":81,"type":79},"2024-05-08",{"date":83,"type":65},"2037-12-30",{"name":5,"class":6},1]