[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ZSky Biotech Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100650777","personalized-neoantigen-pulsed-autologous-dendritic-cell-injections-for-malignant-solid-tumors-100650777",false,"NCT07752953","Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors","Real-World Study of Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections （ZSNeo-DC ）for Malignant Solid Tumors","ZSNeo-DC-RWS","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Male or female participants aged 18 to 75 years, inclusive.\n  2. Histologically or cytologically confirmed malignant solid tumor.\n  3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n  4. Adequate hematologic function, including:\n  5. Adequate hepatic function:\n  6. Adequate renal function:\n  7. Adequate coagulation function:\n  8. Adequate pancreatic function:\n  9. Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.\n  10. Adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection by leukapheresis.\n  11. Left ventricular ejection fraction (LVEF) ≥50%.\n  12. Estimated life expectancy of at least 3 months.\n  13. Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration of study treatment.\n  14. Male participants and women of childbearing potential must agree to use highly effective contraception during treatment and for 3 months after the final administration.\n  15. Ability to understand and voluntarily sign written informed consent.\n  16. Willingness and ability to comply with study procedures and scheduled follow-up assessments.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\n  1. T-cell-derived malignant tumors.\n  2. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n  3. Active autoimmune disease requiring systemic treatment.\n  4. Active uncontrolled bacterial, viral, fungal, or opportunistic infection.\n  5. Known human immunodeficiency virus (HIV) infection.\n  6. Active hepatitis B or hepatitis C infection that is not adequately controlled.\n  7. Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, severe arrhythmia, or congestive heart failure.\n  8. Severe pulmonary, hepatic, renal, neurologic, psychiatric, or other uncontrolled systemic diseases judged by the investigator to interfere with study participation.\n  9. Pregnant or breastfeeding women.\n  10. Receipt of systemic immunosuppressive therapy within 14 days before leukapheresis, except physiologic corticosteroid replacement.\n  11. Receipt of blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days before PBMC collection.\n  12. Inability to undergo leukapheresis.\n  13. Any condition that, in the investigator's opinion, would place the participant at unacceptable risk or compromise study integrity.","ALL","18 Years","75 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a prospective, single-center, open-label, real-world clinical study designed to evaluate the safety, efficacy, and immunogenicity of Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）in patients with malignant solid tumors. The study protocol received approval from the institutional review board and ethics committee of Beidaihe Hospital, adhering to ethical guidelines. Written informed consent was obtained from all participants in accordance with the principles of the Declaration of Helsinki. Approximately 100 patients will be enrolled in multiple tumor-specific cohorts which will be independently statistically analyzed. ZSNeo-DC will be manufactured by Good Manufacturing Practice (GMP). Participants will receive seven subcutaneous injections of personalized DCs administered on Days 1, 8, 15, 22, 36, 50, and 64, either as monotherapy or in combination with immune checkpoint inhibitors according to routine clinical practice. Tumor response, progression-free survival, overall survival, safety, and antigen-specific immune responses will be evaluated throughout the study.",[28,29,30],"Advanced Solid Tumor","Cancer","Malignant Solid Tumor",[32,33,34,35,36],"Personalized Dendritic Cell","Neoantigen Vaccine","Cancer Vaccine","Tumor Immunotherapy","Solid Tumor","RECRUITING","2026-08-03",{"date":40,"type":41},"2026-08-07","ACTUAL",{"date":43,"type":41},"2026-05-01",{"date":45,"type":22},"2030-08-10",{"name":47,"class":48},"ZSky Biotech Inc","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100621027","phase-2-neoantigen-pulsed-autologous-dendritic-cell-vaccine-combined-with-temozolomide-for-newly-diagnosed-glioblastoma-100621027","NCT07365280","Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma","An Open-Label, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 in Combination With Temozolomide as Adjuvant Therapy in Patients With Newly Diagnosed Glioblastoma After Surgery and Concurrent Chemoradiotherapy","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible:\n\nInclusion Criteria\n\n1. Age 18 to 75 years, inclusive\n2. Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)\n3. Molecular diagnosis of IDH1\u002FIDH2 wild-type\n4. Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy\n5. Karnofsky Performance Status (KPS) score of 50 to 100\n6. Adequate hematologic, hepatic, renal, and coagulation function\n7. Availability of sufficient tumor tissue and blood samples for neoantigen identification\n8. Adequate venous access for PBMC collection\n9. Life expectancy greater than 3 months\n10. Willingness to use effective contraception during study treatment and for 3 months thereafter\n11. Ability to understand and willingness to sign written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are ineligible:\n\n1. Not suitable for standard temozolomide-based chemoradiotherapy\n2. Prior participation in another interventional clinical trial within 4 weeks before randomization\n3. Prior implantation of carmustine wafers within 6 months\n4. Known hypersensitivity to temozolomide or dacarbazine\n5. Active autoimmune disease or requirement for systemic immunosuppressive therapy\n6. Active infection including HIV, active hepatitis B or C, or syphilis\n7. Use of systemic immunosuppressive therapy within 30 days before randomization\n8. Uncontrolled cardiovascular, metabolic, or systemic disease\n9. Pregnancy or breastfeeding\n10. Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results",{"count":58,"type":22},78,[60],"PHASE2","This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM).\n\nEligible patients with histologically confirmed, IDH1\u002FIDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone.\n\nThe primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.",[63],"Glioblastoma",[65,66],"DC","Personalized neoantigen-pulsed autologous dendritic cells vaccine","NOT_YET_RECRUITING","2026-01-15",{"date":70,"type":41},"2026-01-26",{"date":72,"type":22},"2026-01-09",{"date":74,"type":22},"2028-12-24",{"name":47,"class":48},""]