Clinical trials of the first Russian CAR-T drug Utjefra (hemagenleucel), developed by the National Research Institute of Hematology of the Ministry of Health, will be completed at the end of 2025. After that, the center will submit registration documents to the Ministry of Health, Elena Parovichnikova, chief consultant hematologist at the Ministry of Health and General Director of the National Research Medical Center of Hematology, told TASS.
«The trial is to be completed at the end of this year. 60 patients will be enrolled in the study, and then, after an analysis, the documents will be submitted to the Russian Ministry of Health for the registration. After using the CAR-T-cell drug produced in our country, patients achieve complete remission», — Parovichnikova said.
Utjefra targets severe cases of oncohematological diseases, specifically addressing resistant forms and relapses of B-cell malignant blood tumors. According to the General Director of the National Research Medical Center of Hematology, the drug has shown high efficacy in B-cell acute lymphoblastic leukemia and B-cell lymphoma.
Parovichnikova added that the indications for the use of CAR-T-cell technology are expanding. Worldwide, indications for CD19 CAR-T cell therapy are expanding: now it is used to target autoimmune diseases. «CAR-T cells can carry not only the chimeric CD19 receptor, but also a large number of chimeric receptors for various antigens, and they are used against numerous diseases, including multiple myeloma and acute myeloid leukemia», — the chief freelance hematologist at the Ministry of Health explained.
Clinical trials of Utjefra, Russia’s first CAR-T development, started in Russia in 2024. As Olga Alyoshina, Head of the Department of Cellular and Immune Therapy at the National Research Medical Center of Hematology, noted, the study is of strategic importance for thousands of patients in need of innovative treatment. In January, the first patient was successfully treated with the Russian medicine.
After successful completion of all stages of clinical trials and registration procedures, it is planned to expand the production of the drug to provide it not only to patients of the National Research Institute of Hematology, but also to other Russian medical institutions. A specialized licensed site is being built at the center. It is scheduled to be launched in 2026.
There is only one registered CAR-T drug in Russia, Kymriah (Tisagenlecleucel) produced by Novartis. It is used for the treatment of acute lymphoblastic leukemia and refractory diffuse B-large cell lymphoma. The cost of the course is about 39 million rubles. The National Medical Research Center of Hematology has received the first license in Russia from the Ministry of Industry and Trade for the manufacture of innovative CAR-T cell therapies.
