[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marzieh Ebrahimi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100568933","phase-2-injection-of-active-allogeneic-natural-killer-cells-in-patients-with-gliomas-100568933",false,"NCT06687681","Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas","Efficacy of the Intrathecal Injection of Active Allogeneic Natural Killer Cells in Patients With High-grade Gliomas; A Multi-center Phase II Clinical Trial","Inclusion Criteria: New diagnosed patients with grade 3 or 4 brain tumor, based on WHO classification, which are included in the one of the following conditions: • Astrocytoma, IDHmutant • Oligodendroglioma, IDH-mutant • Glioblastoma, IDH-wild type • Diffuse midline glioma • Diffuse hemispheric glioma • Diffuse pediatric-type high-grade glioma, IDH-wild type Age range of 3 to 60 years old both sex Lansky\u002FKarnofsky performance score above 60 Obtained informed consent of patients or parents or legal attendance in cases of pediatrics Hemoglobin above 10 gr\u002FdL of blood Absolute granulocyte count (AGC) above 500 per microliter of blood Platelet count above 50000 per microliter of blood INR below 2 and PTT less than 1.5 times of maximum normal value Plasma bilirubin level less than 1.5 times of maximum normal value Plasma hepatic transaminases (ALT and AST) level less than 3 times of maximum normal value Plasma creatinine level less than 1.5 times of maximum normal value -\n\nExclusion Criteria: Evidence of radio necrosis in MRI or MRS Intolerance of new treatment due to emergency condition History of other malignancies History of any immunodeficiency diseases or any immune compromising conditions Rupture of cerebral shunt or unable to perform a lumbar puncture Pregnancy History of uncontrolled chronic diseases such as: Diabetes, CHF, liver cirrhosis, CKD, etc\n\n\\-","ALL","3 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Gliomas are the most common malignant brain tumors, which are often associated with high-grade tumors characterized by an inferior prognosis and low patient survival rates in both children and adults. Surgical removal and tumor resection are the primary treatment approaches for gliomas. In such cases, whole-brain radiation therapy is also employed as a therapeutic option, which itself has significant side effects, and studies have shown limited impact on improving patient survival. Targeted therapy and recently investigated approaches such as targeted therapy have shown some tumor regression, but in most cases, tumor recurrence has been observed after initial regression. Therefore, they have a limited impact on prolonging patient survival. Immunotherapy, particularly immunotherapy with specific immune cells, can effectively identify and eliminate cancer cells and has been utilized as a new approach in the past two decades, especially in cancers where conventional methods have limited success. Among the effective immunotherapy methods, using natural killer cells (NK cells) can be one of the promising approaches. Currently, phase I clinical trials have been conducted by our research group in patients with gliomas.",[27,28],"Glioma Glioblastoma Multiforme","High Grade Glioma (III or IV)",[30,31,32,33,34],"natural killer cells","Brain glioma","NK cells","glioblastoma","high grade gliomas","RECRUITING","2025-04-05",{"date":38,"type":39},"2025-04-09","ACTUAL",{"date":41,"type":39},"2024-11-25",{"date":43,"type":21},"2027-11-25",{"name":45,"class":46},"Marzieh Ebrahimi","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100567905","phase-1-safety-and-efficacy-of-systemic-allogenic-nk-cells-in-rr-neuroblastoma-100567905","NCT06674265","Safety and Efficacy of Systemic Allogenic NK Cells in R\u002FR Neuroblastoma","Evaluation of Safety and Efficacy Evaluation Post Intravenous Infusion of Activated NK Cells in Recurrent and Refractory High-risk Neuroblastoma Patients","Inclusion Criteria:\n\n1. High-risk neuroblastoma that is resistant to standard induction therapy based on COG (Children's Oncology Group) criteria (according to INRG criteria and having received at least 4 cycles of multi-drug induction chemotherapy, and not responding to conventional treatments).\n2. Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy.\n3. A minimum life expectancy of 6 months.\n4. Patients must have a pathological diagnosis of neuroblastoma and\u002For confirmation of tumor cells in the bone marrow with increased urinary catecholamines.\n5. Measurable residual disease based on imaging findings using Curie scoring or MIBG or PET imaging criteria (1: measurable tumor of at least 10 mm in one dimension on MRI or CT scan with positive uptake on I-123 MIBG scan (\"MIBG avid\") oOR 2): increased FDG uptake on 18F-FDG PET-CT or PET-MRI (\"PET avid\")).\n\n   \\-\n\nExclusion Criteria:\n\n1. Insufficient bone marrow function: Platelet count \\> 50,000\u002FµL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin \\> 10 grams per deciliter.\n2. Insufficient liver function: Plasma bilirubin level more than 1.5 times the upper limit of normal (ULN). SGPT (ALT) at least three times the upper limit of normal (a level of 45 units per liter is considered the upper limit of normal).\n3. Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR \\\u003C 70 ml\u002Fmin\u002F1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age\u002Fgender.\n4. Insufficient central nervous system function if seizures are present, entry into the study is not possible and if seizures are not well controlled with anticonvulsant drugs.\n\n3- Insufficient cardiovascular function Shortening fraction \\\u003C 27% by ECHO OR Ejection fraction \\\u003C 50% by ECHO or gated radionuclide study.\n\n4- Insufficient pulmonary function evidence of dyspnea at rest. Exercise intolerance. Chronic need for oxygen and room air pulse oximetry \\\u003C 94% if pulse oximetry evaluation is clinically indicated. Presence of current pleural or pericardial effusion.\n\n5- Inability to tolerate new treatment due to emergency conditions. 6- Elevated catecholamines (more than twice the ULN) or sole involvement of bone marrow (bone marrow positive for NB as the only evaluable disease without confirmatory pathology report).\n\n7- Receiving 0.5 mg\u002Fkg\u002Fday of systemic steroids (equivalent to prednisone) for at least 7 days before enrollment.\n\n8- Receiving CYP3A4 inducers or inhibitors at least 7 days before study enrollment.\n\n9- Diagnosis of any other malignancy alongside the diagnosis of neuroblastoma. 10- Diarrhea \\> Grade 2 (4 to 6 stools per day). 11- Significant illness not covered by exclusion criteria but interfering with the study process or increasing the intensity of treatment with NK cells.\n\n12- Participation in another clinical trial. 13- Severe impairment of major organ functions, such as renal, cardiac, hepatic, neurological, pulmonary, or gastrointestinal toxicity above Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTC v5.0).\n\n14- Inability to comply with protocol requirements. 15- Lack of confirmed and signed consent by the patient's guardians. 16- Evidence of HIV disease (Human Immunodeficiency Virus) or positive serology for HIV.","2 Years","16 Years",{"count":58,"type":21},10,[60],"PHASE1","The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory\u002Frecurrent high-risk neuroblastoma.\n\nIs the injection of allogenic nk cells safe in patients with R\u002FR high-risk neuroblastoma? Is the injection of allogenic nk cells effective in patients with R\u002FR high-risk neuroblastoma? We will compare the NK cell administration group with a control group that receives conventional treatment to determine whether the intervention is safe and effective",[63,64,65],"Neuroblastoma, Recurrent, Refractory","Neuroblastoma (NB)","Neuroblastoma in Children",[67,68,69,70,71],"Neuroblastoma","High-Risk Neuroblastoma","Natural Killer Cell","Nk Cell","adrenal gland",{"date":38,"type":39},{"date":74,"type":39},"2024-11-10",{"date":76,"type":21},"2026-11",{"name":45,"class":46},""]