[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567905":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":63,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":18,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":18,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Kian Immune Cell Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","ACTIVE_COMPARATOR","Patients with refractory\u002Frecurrent neuroblastoma will receive 3 to 5 systemic injections of allogeneic NK cells during the intervals between their chemotherapy courses",[13],"Biological: Allogenic NK cells infusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","Patients in the control group will receive no cells and just conventional treatments will be administered to them.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BIOLOGICAL","Allogenic NK cells infusion","Natural Killer (NK) cells are extracted from a healthy donor through apheresis and processed in a clean room using the CLINIMACS device. After quality assessment, these cells are stored at -198°C until needed. When required, the cells are thawed, washed, and evaluated for viability and sterility before being administered to the patient at a dosage of 5 × 10\\^6 cells per kilogram of body weight. Two further injections may be considered based on the patient's response and confirmed improvement via MRI MIBG. Injections are scheduled seven to ten days after each chemotherapy course according to the standard treatment protocol.",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Dr. Marzieh Ebrahimi, PhD. in Medical Immunology","Royan Institute","STUDY_CHAIR",{"name":31,"affiliation":32,"role":33},"Dr. Mohammad Faranoush, Pediatric Oncologist","Iran University of Medical Science","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":18,"email":39},"Dr. Marzieh Ebrahimi","CONTACT","+98 9123448359","m.ebrahimi@royan-rc.ac.ir",[41],{"facility":42,"status":43,"city":44,"state":18,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Rasoul Akram Hospital","RECRUITING","Tehran","1445613131","Iran","IR",{"type":49,"coordinates":50},"Point",[51,52],51.42151,35.69439,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":18,"email":58},"Dr. Mohammad Faranoush, Professor","+98 9121590917","faranoush.m@iums.ac.ir",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Marzieh Ebrahimi","Professor of Medical Immunology",[64,66],{"name":28,"class":65},"OTHER_GOV",{"name":67,"class":68},"Iran University of Medical Sciences","OTHER","100567905","phase-1-safety-and-efficacy-of-systemic-allogenic-nk-cells-in-rr-neuroblastoma-100567905",false,"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.","ALL","2 Years","16 Years",{"count":80,"type":81},10,"ESTIMATED","INTERVENTIONAL",[84],"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",[87,88,89],"Neuroblastoma, Recurrent, Refractory","Neuroblastoma (NB)","Neuroblastoma in Children",[91,92,93,94,95],"Neuroblastoma","High-Risk Neuroblastoma","Natural Killer Cell","Nk Cell","adrenal gland","2025-04-05",{"date":98,"type":99},"2025-04-09","ACTUAL",{"date":101,"type":99},"2024-11-10",{"date":103,"type":81},"2026-11",{"name":61,"class":6},1]