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IRCT20201202049568N1 IRCT 2021-02-20 Tehran University of Medical Sciences Allogenic Natural Killer cell therapy in relapsed Neuroblastoma pediatric patients NKNB The safety and efficiency evaluation of allogenic Natural Killer cell therapy in relapsed Neuroblastoma pediatric patients post hematopoietic stem cell transplantation: Phase I clinical study 2021-02-19 anticipated 5 Complete https://irct.ir/trial/54326 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Neuroblastoma. Intervention group: NK cells that were isolated by CliniMACS from apheresis samples will be expanded over 10 days in a specific media with 10% serum and will be infused in combination with cyclophosphamide 60mg/kg on day -3 and day -2 prior to the NK cell infusion.NK cells will be injected intravenously at doses of 10 million and 50 million per kilogram of body weight at three-week intervals.. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be shared. When: January 2023 To whom: academic institutions and hospitals Conditions: No limitation Where to obtain: Rashin Mohseni rashin_mohseni@yahoo.com How to obtain: One year after the intervention Comments:
public Rashin Mohseni
Gharib St., Keshavarz Blvd,
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6147 9000 rashin_mohseni@yahoo.com Tehran University of Medical Sciences scientific Rashin Mohseni
Pediatric Cell Therapy Research Center, Children's Medical Center Hospital, Gharib Ave, Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 8444 rashin_mohseni@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Any amount of neuroblastoma tumor cells in the bone marrow that can be seen from at least one aspiration sample Tumors seen on CT in at least one soft tissue. Have at least 1 MIBG- lesion with a score of 1-2 Curie The patient has a life expectancy of at least 12 weeks. The function of the patients organs must be acceptable. Patient age from 1 to 15 years 1 year 15 years Both Active or uncontrollable infection History of allergies or any hypersensitivity to animal proteins Heart failure Serious mental and physical disabilities Participation in any other clinical trial C74.90 Malignant neoplasm of unspecified part of unspecified adrenal gland Treatment - Other Intervention group: NK cells that were isolated by CliniMACS from apheresis samples will be expanded over 10 days in a specific media with 10% serum and will be infused in combination with cyclophosphamide 60mg/kg on day -3 and day -2 prior to the NK cell infusion.NK cells will be injected intravenously at doses of 10 million and 50 million per kilogram of body weight at three-week intervals. To measure tumor response after infusion of expanded activated NK cells. Response will be assessed as defined by Revised International Neuroblastoma Response Criteria 2017. Timepoint: Each 6 month Over 2 years. Method of measurement: Disease status at primary and metastatic soft tissue sites will be assessed using MIBG scans or PET scan as applicable. To measure the numbers of infused NK cells in peripheral blood at specific time-points after NK cell infusion. Timepoint: before intervention and 2, 4 , 6 month after intervention. Method of measurement: NK cells will be identified by flow cytometry in peripheral blood and their percentages and absolute numbers will be calculated. Tehran University of Medical Sciences Approved 2020-11-21 Ethics committee of Tehran University of Medical Sciences Pediatric Cell Therapy Research Center, Keshavarz Blvd, Dr Gharib St. Tehran Tehran Iran (Islamic Republic of)