BCD-225-2 "An Open-Label, Single-Arm Study of Ascending Doses of BCD-225 in Combination with BCG Vaccine1 Administered Intravesically in Patients with High-Risk Nonmuscle Invasive Bladder Cancer Who Had Not Previously Received Intravesical BCG Therapy".
During the clinical trial of BCD-225-2, the safety, pharmacokinetics, pharmacodynamics, immunogenicity and pilot efficacy parameters of BCD-225 in combination with BCG (hereinafter referred to as BCG) will be evaluated during multiple intravesical administration in patients with nonmuscle invasive bladder cancer who had not previously received BCG therapy and who:
Have reached the age of 18 years at the time of signing the informed consent form;
Have had a histologically confirmed diagnosis of bladder cancer, which:
Is represented by a classic urothelial, or transitional cellular carcinoma. A mixed histological subtype of the tumor is allowed, provided that classical urothelial carcinoma predominates;
Refers to carcinoma in situ2 (CIS) (with or without Ta/T1 papillary carcinoma) and/or to non-invasive high-grade papillary carcinoma (Ta HG) or tumor spreading to subepithelial connective tissue (T1), according to TNM classification3;
Is BCG-naïve (subject has not received BCG vaccine instillation);
Have no evidence of Ta/T1 tumor after transurethral resection (TUR) / biopsy (residual CIS is allowed);
Have an ECOG performance score4 of 0-1.
The clinical trial protocol provides for TUR/biopsy or review of archival biomaterials (i.e., a tumor sample collected before the signing of the Clinical Trial Participant Information Sheet with the informed consent form).
This clinical trial has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Investigator. In particular, the exclusion criteria are:
History or screening evidence5 of muscle-invasive localized (stages II–IIIA), locally advanced (stages IIIB–IVA), or metastatic bladder cancer (stage IVB);
History or screening evidence of urothelial carcinoma of extravesical localization (renal calyces, pelvis, ureter, or urethra);
Scheduled radical cystectomy at the time of the study;
Residual urine volume ≥ 50 mL;
History or screening evidence of other malignant neoplasms within the last 5 years (including upper urinary tract and prostate tumors), except squamous cell and basal cell skin cancer, carcinoma in situ of the cervix and breast;
History of use of at least one of the following:
BCG vaccines and/or IL-15 superagonists6 for immunotherapy of bladder cancer;
Checkpoint inhibitors for the treatment of bladder cancer;
Radiation therapy for bladder cancer;
HIV infection, active hepatitis B, active hepatitis C;
Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast agents).
The clinical trial of BCD-225-2 is being conducted in study centers across the Russian Federation, including Moscow, St. Petersburg, Nizhny Novgorod, Barnaul, Krasnoyarsk, Omsk, Volzhsky, Ivanovo, Ufa, and Novosibirsk.
To ask questions about potential participation in a clinical trial, including contact details of study centers, please use a special form at ct.biocad.ru.
The Investigator will inform the potential participant about other eligibility criteria and contraindications for participation in this clinical trial. The potential participant should read the complete study information and consult with the Clinical Investigator and/or their attending physician.
Clinical Study Authorization No. 86 dated March, 11 2026 of the Ministry of Health of the Russian Federation and the list of authorized study centers are published in the State Register of Medicines.
BCG - in the context of this article is an antitumor vaccine, which is a specially attenuated mycobacterium of the vaccine strain Mycobacterium bovis. This vaccine is widely used worldwide to treat patients with non-muscle invasive bladder cancer.
In situ (translated from Latin) is a term used in oncology to refer to a tumor in its initial stages of development.
TNM is an international staging system for malignant neoplasms that describes the extent of cancer based on three components: T (Tumor - size and extension of the primary tumor), N (Nodus - regional lymph node involvement), and M (Metastasis - presence of distant metastases).
ECOG scale is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical trial according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.
IL-15 is a signaling substance of the body that activates IL-15 receptors located on the surface of immune cells, leading to the activation of antitumor and antiviral responses.