Utzhefra (hemagenlekleutzel)

History

2025: The first CAR-T cell therapy in Russia began to successfully treat cancer

The National Medical Research Center () NMIC of Hematology Ministry of Health Russia in January 2025 announced the successful completion of the first stage of clinical trials of the domestic CAR-T cell drug Utzhefra in the first patient with blood cancer.

According to TASS, the 59-year-old patient received two doses of the drug in December 2024, after which she confirmed a complete response to therapy without serious complications. Olga Aleshina, head of the department of cellular and immune therapy at the National Medical Research Center of Hematology of the Ministry of Health of Russia, stressed that specialists continue to monitor blood indicators, CAR-T cell activity and the condition of vital organs.

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Фото: Freepik

Clinical studies of the first Russian CAR-T-cell drug "Utzhefra" started at the National Medical Research Center of Hematology in December 2024. The tests will involve 60 patients with relapses of B-cell malignancies of the blood, having the CD19 antigen on the surface of tumor cells.

The drug Utzhefra, developed in the transplant immunology laboratory of the National Medical Research Center of Hematology, has successfully passed all stages of preclinical studies. The generic name of the drug is hemagenlekleutzel, it is intended for the treatment of B-cell malignancies with the CD19 antigen.

After the administration of the drug, the first patient spent a week under observation in the intensive care unit, which is provided for by the study protocol. Then she was transferred to the hematology department, followed by observation in a day hospital.

All study participants will undergo regular medical examinations, including blood tests and instrumental studies, for a year after administration of the drug to control remission and determine the status of the underlying disease. Additionally, a 15-year follow-up period was established to assess possible delayed complications.^[1]

2024: Russia's first CAR-T cell therapy approved

On November 12, 2024, the Ministry health care Russia issued National Medical Research Center for Hematology permission to conduct clinical trials of the first domestic CAR-T-drug Utzhefra (hemagenleukleutzel).

Phase I-II studies will be conducted in 60 patients with relapses and refractory forms of B-cell lymphoproliferative diseases. Clinical trials are scheduled to be completed by the end of 2025.

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Фото: Freepik

The development was preceded by a number of important stages: in September 2023, preclinical tests on laboratory animals were completed, and in October 2024, the National Medical Research Center of Hematology received a license from the Ministry of Industry and Trade to produce CAR-T drugs on its own site.

The center is creating a production infrastructure with a potential capacity of up to 600 units of the drug per year. In 2022, ₽764 million were allocated for the construction and equipment of the new building. In September 2024, the government additionally allocated ₽82,3 million for the purchase of 39 pieces of equipment for the development of high-tech drugs.

Apollinaria Bogolyubova-Kuznetsova, head of the CAR-T department at the National Medical Research Center of Hematology and head of the laboratory of transplantation immunology, noted: "This is the first study of a domestic CAR-T-cell drug, which is supposed to be completed by the end of 2025."

Until November 2024, only one drug of this type was registered in Russia - Kymriya (tisagenlekleutzel) of the Swiss company Novartis, approved in 2023 for the treatment of acute lymphoblastic leukemia and refractory diffuse B-large cell lymphoma. The cost of one course of imported drug is ₽39 million.

Upon completion of clinical studies, the National Medical Research Center of Hematology plans to submit documentation for obtaining a marketing authorization for bringing the drug to the Russian market.^[2]

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