Phase 1 Study of BCD-245 in Subjects With Neuroblastoma

Inclusion Criteria:

* Age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form
* Established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine
* Relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site
* Satisfactory performance status (\>70 on the Lansky or Karnofsky scale)
* Life expectancy \>8 weeks

Exclusion Criteria:

* Indications for radiation therapy, surgical intervention for the primary disease at screening
* Isolated CNS relapse of neuroblastoma
* Planned use of any anticancer drugs concomitantly with BCD-245 in this clinical trial
* The need for continuous use of anticonvulsants
* Clinically significant neurological deficit or grade \>2 peripheral neuropathy (CTCAE 5.0)
* The need or probable need for systemic continuous use of glucocorticosteroids or other immunosuppressive drugs
* Signs of respiratory distress (dyspnea at rest and oxygen saturation \<94% without oxygen supplementation)
* Any severe organ dysfunction (\> CTCAE 5.0 severity grade 2) at screening, except for hematological abnormalities.
* Body weight less than 10 kg.
* Subject receiving anti-GD2 monoclonal antibody therapy within 6 weeks or less prior to intended study drug infusion