Clinical Study BCD-245-2/WINNER – An Open-Label Clinical Study of the Efficacy and Safety of BCD-245 in Combination with Chemotherapy in Subjects with Relapsed/Refractory Neuroblastoma.
The purpose of this clinical study is to assess the efficacy, safety, immunogenicity, and pharmacokinetics of BCD-245 in combination with chemotherapy in subjects with relapsed/refractory neuroblastoma who:
Have a diagnosis of neuroblastoma based on:
histological examination of the tumor tissue (with or without immunohistochemical examination)
or the presence of typical tumor agglomerates in the bone marrow and/or metaiodobenzylguanidine-accumulating lesion(s) and increased levels of catecholamine metabolites in the serum and/or urine.
Have reached the age of 1 year.
Have a satisfactory overall condition (Lansky or Karnofsky score >50).
This study uses exclusion criteria (criteria of ineligibility for the particular clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:
Prior systemic therapy for relapsed or refractory disease.
Prior use of chemotherapy drugs for relapsed/refractory neuroblastoma (pop-up window: the patient can check the detailed names of the drugs with the attending physician).
Planned use of any anticancer drugs concomitantly with the investigational product BCD-245 during the participation in the clinical study.
A period of less than 2 weeks (before the expected start of study therapy) after previous systemic therapy for the underlying disease, surgery and/or incomplete resolution (and/or incomplete recovery) of sequelae and/or presence of complications of previous therapy for the underlying disease and/or surgery (in the opinion of the Investigator).
A period of less than 6 weeks (before the expected start of study therapy) after previous auto-HSCT or MIBG therapy for the underlying disease and/or incomplete resolution of sequelae of previous therapy for the underlying disease (in the opinion of the Investigator).
A period of less than 6 weeks (before the expected start of study therapy) after therapy with anti-GD2 monoclonal antibodies.
HIV infection, hepatitis B.
Isolated CNS relapse of neuroblastoma (according to imaging studies).
The BCD-245-2/WINNER study will be conducted at the study centers of Moscow, St. Petersburg, Chelyabinsk, and Krasnodar.
If necessary, following agreement with the study doctor and consent of the clinical study participant or his/her legal representative, transportation services may be provided for trips required during the participation in this study. The study doctor will explain in detail the procedure of ordering transportation services to the clinical study participant or his/her legal representative.
When transportation services are ordered, no information about the clinical study participant or his/her legal representative will be displayed. collected, or transmitted to the Sponsor.
The study doctor will tell the potential participant (and/or his/her legal representative) about the other eligibility criteria and contraindications for participation in this clinical study. The potential participant (and/or his/her legal representative) should read the full information about the study and consult the study doctor and/or attending physician.
Clinical Study Authorization No. 621 of the Ministry of Health of the Russian Federation dated October 30, 2023.