Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease

Inclusion Criteria: 1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG). 2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence. 3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria). 4. Life expectancy ≥6 months. 5. Obtaining the informed written consent of the patient and/or statutory representative for the treatment. 6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding. 7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study. Exclusion Criteria: 1. Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders. 2. Patients with neurological toxicities of ≥2 CTCAE WHO grade. 3. Active life-threatening infection until stabilization of the patient's condition. 4. Pregnancy and / or lactation. 5. Sexually active patients who refuse to use an effective method of contraception. 6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study. 7. Radiotherapy within 3 weeks prior to the start of the study. 8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL). 9. Lack of informed written consent to treatment.