Actively Recruiting
Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2026-01-29
5
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neuroblastoma (NB) is a serious cancer of the sympathetic nervous system mostly affecting children, with high-risk stage 4 patients facing the poorest outcomes. This trial focuses on patients with refractory disease who respond poorly to initial therapy and those with relapsed or progressive NB. The study aims to improve treatment responses and survival by combining chemotherapy with immunotherapy and natural killer (NK) cell therapy to overcome drug resistance. The trial has two groups: Arm A for patients with refractory disease and Arm B for those with relapsed or progressive disease. Patients in Arm A will undergo an intensified induction phase that includes collection of mononuclear cells to grow autologous NK cells, followed by one course of chemotherapy (irinotecan and temozolomide) and four courses of combined chemoimmunotherapy with dinutuximab beta and NK cells every 21 days. Arm B patients receive a similar pattern but with five courses of chemoimmunotherapy after blood collection for NK cell preparation. NK cells are transfused on Day 7 of each treatment cycle. Later treatment phases like surgery and radiotherapy occur outside this study. Participants will be monitored for tolerability and side effects immediately after treatment courses. The study tracks response rates, overall survival, event-free survival, progression-free survival, and relapse-free survival at multiple time points up to five years after diagnosis. Patient quality of life is also assessed. The total duration of involvement depends on treatment and follow-up schedules, with detailed clinical and laboratory evaluations throughout the study.
CONDITIONS
Brief Title
Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed voluntary informed consent to participate in the clinical trial
- Histologically verified diagnosis of neuroblastoma or ganglioneuroblastoma
- Classified as high-risk according to German Society of Pediatric Oncology and Hematology criteria
- Aged between 18 months and 18 years
- For Arm A: refractory disease with poor response after induction therapy
- For Arm B: relapsed or progressive disease with new or increased tumor lesions
- Performance status of 70% or higher on Lansky or Karnofsky scale
- Expected life expectancy of at least 12 weeks
- No signs of drug-induced neuropathy or neuropathic pain
- Adequate liver function with ALT and AST less than 5 times normal
- Adequate kidney function with creatinine clearance or GFR above 60 mL/min/1.73 m2
- Coagulation parameters within specified ranges
- No clinical signs of heart failure; LVEF of 55% or greater
- Adequate respiratory function with oxygen saturation above 94% on room air
- Completion of comprehensive tumor assessment
You will not qualify if you...
- No signed informed consent
- Missing comprehensive pre-treatment assessment results
- Classified as low or intermediate risk for neuroblastoma or ganglioneuroblastoma
- Good response or progressive disease at end of induction therapy in Arm A
- Central nervous system or leptomeningeal involvement in relapsed/progressive disease
- History of severe intolerance to study drugs or supportive care medications
- Complications or comorbidities preventing treatment under this protocol
- Need for medications that interact with study drugs
- Signs of heart failure with LVEF 55% or less
- Chronic kidney disease stage III or worse or acute kidney injury
- Pregnancy; females of childbearing potential must have pregnancy testing
- Mental illness impairing understanding or adherence to study requirements
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 15 weeks depending on disease group
Participants receive intensified induction therapy involving a procedure to collect blood cells for NK cell cultivation, followed by one course of chemotherapy and multiple courses of chemoimmunotherapy combined with autologous NK cell therapy. Treatment cycles occur every 21 days with NK cell transfusions on Day 7 of each chemoimmunotherapy course.
5 to 6 cycles with visits every 21 days
Trial Site Locations
Total: 1 location
1
National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
Moscow, Russia, 117198
Actively Recruiting
Research Team
T
Tatyana V Shamanskay, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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