Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT05782959
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT05782959
Study Brief:
Protocol Section:
NCT05782959