Tests donor natural killer cell infusion in children with recurrent neuroblastoma
Tests infused donor natural killer cells in children with returning high-risk neuroblastoma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma
Key facts
- Where
- Tehran, IranSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with high-risk neuroblastoma that did not respond to treatment or came back. It tests safety and effect of infused donor NK cells.
- Age
- 2 Years to 16 Years
- Sex
- All sexes can join.
- Disease stage
- High-risk neuroblastoma resistant to standard induction therapy (at least 4 cycles of multi-drug chemotherapy), or relapsed or progressed after stem cell transplant or aggressive therapy. Measurable disease on imaging is needed.
- Earlier treatment
- At least 4 cycles of multi-drug induction chemotherapy without response; relapse or progression after autologous peripheral blood stem cell transplantation or aggressive therapy.
- Biomarker or test result
- Neuroblastoma confirmed by pathology and/or tumor cells in the bone marrow with increased urinary catecholamines. Imaging must show MIBG-avid or PET-avid disease.
Main reasons for not taking part
- Poor bone marrow, liver, kidney, heart, lung or nervous system function
- Another cancer besides neuroblastoma
- HIV disease or positive HIV test
- Taking steroids 0.5 mg/kg/day or more for at least 7 days, or CYP3A4 inducers or inhibitors, before enrollment
- Taking part in another clinical trial
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 16 years old?
Source: NCT06674265, who can take part
Where in Iran
- Rasoul Akram hospitalTehran, IranContact: Dr. Mohammad Faranoush, ProfessorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Marzieh Ebrahimi
- Trial code
- NCT06674265
- Record updated
- 9 April 2025
- Original description
The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory/recurrent high-risk neuroblastoma.Read full original descriptionShow less
Evaluation of Safety and Efficacy Evaluation Post Intravenous Infusion of Activated NK Cells in Recurrent and Refractory High-risk Neuroblastoma Patients
The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory/recurrent high-risk neuroblastoma.
Is the injection of allogenic nk cells safe in patients with R/R high-risk neuroblastoma? Is the injection of allogenic nk cells effective in patients with R/R 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
Inclusion: 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); Evidence of relapse or progression of neuroblastoma after autologous peripheral blood stem cell transplantation or aggressive therapy; A minimum life expectancy of 6 months; Patients must have a pathological diagnosis of neuroblastoma and/or confirmation of tumor cells in the bone marrow with increased urinary catecholamines; 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")); -.
Exclusion: Insufficient bone marrow function: Platelet count > 50,000/µL, independent of transfusion (no platelet transfusion within one week). Absolute neutrophil count (ANC) maximum of 500 per microliter. Hemoglobin > 10 grams per deciliter; 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); Insufficient kidney function: Creatinine clearance or estimated radioisotope GFR < 70 ml/min/1.73m². Plasma creatinine level more than 1.5 times the upper limit of normal based on age/gender; 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; 3- Insufficient cardiovascular function Shortening fraction < 27% by ECHO OR Ejection fraction < 50% by ECHO or gated radionuclide study; 4- Insufficient pulmonary function evidence of dyspnea at rest. Exercise intolerance. Chronic need for oxygen and room air pulse oximetry < 94% if pulse oximetry evaluation is clinically indicated. Presence of current pleural or pericardial effusion; 5- 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); 7- Receiving 0.5 mg/kg/day of systemic steroids (equivalent to prednisone) for at least 7 days before enrollment; 8- Receiving CYP3A4 inducers or inhibitors at least 7 days before study enrollment; 9- 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; 12- 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); 14- 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.