Actively Recruiting
Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma
Led by Marzieh Ebrahimi · Updated on 2025-04-09
10
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Marzieh Ebrahimi
Lead Sponsor
R
Royan Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 16 years
- Diagnosed with high-risk neuroblastoma resistant to standard induction therapy based on COG criteria
- Evidence of relapse or progression after autologous peripheral blood stem cell transplantation or aggressive therapy
- Minimum life expectancy of 6 months
- Pathological diagnosis of neuroblastoma or tumor cells in bone marrow with increased urinary catecholamines
- Measurable residual disease by imaging (MRI or CT scan with positive MIBG uptake or increased FDG uptake on PET scans)
You will not qualify if you...
- Platelet count below 50,000/μL without transfusion in the past week
- Absolute neutrophil count below 500 per microliter
- Hemoglobin below 10 grams per deciliter
- Plasma bilirubin level more than 1.5 times the upper limit of normal
- SGPT (ALT) level at least three times the upper limit of normal
- Creatinine clearance or GFR below 70 ml/min/1.73m²
- Plasma creatinine level more than 1.5 times the upper limit of normal for age/gender
- Uncontrolled seizures or insufficient central nervous system function
- Shortening fraction below 27% or ejection fraction below 50% by heart function tests
- Evidence of severe lung issues including dyspnea at rest or oxygen dependence
- Inability to tolerate new treatment due to emergency conditions
- Elevated catecholamines more than twice the upper limit of normal or sole bone marrow involvement without pathology confirmation
- Receiving systemic steroids at 0.5 mg/kg/day or higher for at least 7 days before enrollment
- Use of CYP3A4 inducers or inhibitors within 7 days before enrollment
- Diagnosis of other malignancies alongside neuroblastoma
- Diarrhea greater than Grade 2 severity
- Significant illness interfering with study or increasing treatment intensity
- Participation in another clinical trial
- Severe organ function impairments above Grade 2 toxicity
- Inability to comply with study protocol
- Lack of signed consent from guardians
- Positive HIV infection or serology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rasoul Akram Hospital
Tehran, Iran, 1445613131
Actively Recruiting
Research Team
D
Dr. Marzieh Ebrahimi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here