[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytokine-induced-killer-cells\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytokine-induced-killer-cells":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":37,"locationsCount":4},"100568720","optimizing-cytokine-induced-killer-cells-in-glioblastoma-patients-100568720",false,"NCT06684899","Optimizing Cytokine-Induced Killer Cells in Glioblastoma Patients","An In-depth Appraisal of Cytokine-induced Killer Cells in Glioblastomas Patients","KillGlio","Inclusion Criteria for the glioblastoma (GBM) cohort:\n\n* Age ≥18 years.\n* Subject is willing and able to provide informed consent for participation in the study.\n* Subject with a documented diagnosis of GBM (WHO criteria 2021), as confirmed by reference histopathology at San Raffaele Hospital.\n\nInclusion Criteria for the Healthy Volunteer Cohort:\n\n* Age ≥18 years.\n* Subject is willing and able to provide informed consent for participation in the study.\n* Subjects In good general health as evidenced by medical history\n\nExclusion Criteria:\n\n* Subject is not willing or able to provide informed consent for participation in the study. - Pregnancy\n* Presence of an acute infection requiring active treatment.\n* Documented ematological abnormalities: leukocytes \\\u003C 3,000\u002Fμl or lymphocytes \\\u003C 500\u002Fμl or neutrophils \\\u003C 1,000\u002Fμl or hemoglobin \\\u003C 9 g\u002F100 ml or thrombocytes \\\u003C 100,000\u002Fμl, based on the most recent laboratory tests performed for clinical practice.\n* Documented immune deficiency\n* Documented autoimmune disease.\n* Documented positive serology for HIV or HBs antigen.",true,"ALL","18 Years",{"count":21,"type":22},40,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational cohort study is to assess the optimal in vitro production protocol for generating Cytokine-Induced Killer (CIK) cells, a type of T lymphocyte, and to evaluate the potential adverse effects of concurrent neuro-oncology therapies on these cells in glioblastoma (GBM) patients. Additionally, the study aims to explore mechanisms to enhance the antitumor activity of CIK cells against GBM by investigating GBM's immune escape mechanisms that may counteract the Human Leukocyte Antigen (HLA)-independent activity of CIK cells.\n\nThe main questions it aims to answer are:\n\nWhat is the most effective in vitro production protocol for generating highly active CIK cells from GBM patients? Do concurrent chemoradiotherapy or steroid treatments interfere with the activation or efficacy of CIK cells? What are potential strategies to counteract GBM immune escape mechanisms against CIK cells? Researchers will compare CIK cells produced under different protocols, including the use of media supplemented with commercial blood derivatives, to identify the most effective protocol and evaluate the impact of concomitant therapies on CIK cell functionality.\n\nParticipants will:\n\nUndergo a single peripheral blood collection (GBM patients and healthy controls).\n\nHave mononuclear cells isolated from their blood samples and expanded in vitro as CIK cells using various production protocols.\n\nHave their CIK cells tested in vitro to assess activation status and antitumor activity, identifying optimal production methods and potential strategies to overcome GBM immune escape.",[26,27],"Glioblastoma","Cytokine-Induced Killer Cells",[26,27],"NOT_YET_RECRUITING","2024-11-12",{"date":32,"type":33},"2024-11-14","ACTUAL",{"date":35,"type":22},"2024-11",{"date":35,"type":22},{"name":38,"class":39},"IRCCS San Raffaele","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100247241","phase-4-effect-of-cytokine-induced-killer-cells-for-advanced-malignant-gliomas-100247241","NCT02496988","Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas","A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas","Inclusion Criteria:\n\n* Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma.\n* No more than 3 prior relapses or prior systemic treatments.\n* Recurrent disease documented by MRI after prior therapy.\n* Must have at least one site of bidimensionally measurable disease:\n\narchived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment.\n\n* Completed at least one full cycle of temozolomide of 200 mg\u002Fm2\u002Fday administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.\n* Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.\n* At least 18 years old.\n* Both men and women must practice adequate contraception.\n* Informed consent.\n\nExclusion Criteria:\n\n* Progressed while on temozolomide.\n* Evidence of acute intracranial or intratumoral hemorrhage \\> Grade 1.\n* Not recovered from the toxic effects of prior therapy.\n* Pregnant or breast feeding.\n* History of diabetes mellitus.\n* Uncontrolled intercurrent illness.\n* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.\n* HIV positive.\n* Diagnosis of another malignancy may exclude subject from study.","80 Years",{"count":49,"type":22},120,"INTERVENTIONAL",[52],"PHASE4","The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.",[27,55],"Advanced Milignant Gliomas",[27,57,58],"Milignant Gliomas","Temozolomide","2015-07-13",{"date":61,"type":22},"2015-07-14",{"date":63,"type":4},"2015-07",{"date":65,"type":22},"2030-07",{"name":67,"class":39},"The First People's Hospital of Changzhou",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":47,"enrollmentInfo":75,"targetDuration":4,"studyType":50,"phases":77,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":88,"locationsCount":4},"100247074","phase-1-effect-of-cytokine-induced-killer-cells-for-stage-i-ii-malignant-gliomas-100247074","NCT02494804","Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas","A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas","Inclusion Criteria:\n\nHistologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).\n\nReceived prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.\n\nCompleted at least one full cycle of temozolomide of 200 mg\u002Fm2\u002Fday administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.\n\nKarnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.\n\nAt least 18 years old. Both men and women must practice adequate contraception. Informed consent.\n\nExclusion Criteria:\n\nProgressed while on temozolomide. Evidence of acute intracranial or intratumoral hemorrhage \\> Grade 1. Not recovered from the toxic effects of prior therapy. Pregnant or breast feeding. History of diabetes mellitus. Uncontrolled intercurrent illness. Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.\n\nHIV positive. Diagnosis of another malignancy may exclude subject from study.",{"count":76,"type":22},80,[78,79],"PHASE1","PHASE2","The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.",[27,57],[27,57,58],"2015-07-08",{"date":85,"type":22},"2015-07-10",{"date":63,"type":4},{"date":65,"type":22},{"name":67,"class":39}]