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The First Clinical Trial of a Domestic CAR T-Cell Drug Has Begun

18.11.2024

The NMRC for Hematology of the Ministry of Health of the Russian Federation has received permission from the Ministry of Health of the Russian Federation to conduct clinical trials of the first domestic CAR T-cell drug for the treatment of malignant blood diseases. The drug, developed at the NMRC for Hematology, was named “Utzhefra”. 

The development of an innovative cellular drug for the treatment of B-cell malignant blood tumors has been actively conducted at the NMRC for Hematology since 2022. The new drug is produced based on the patient's own T-lymphocytes. After sampling, the cells are genetically modified using a viral vector. As a result, a receptor (CAR) appears on their surface, which is able to recognize a target on the surface of a cancer cell and destroy it. CAR T-cell therapy makes it possible to achieve unprecedented results in the treatment of B-cell acute leukemia and lymphomas. 

The innovative cellular drug will be used to treat particularly aggressive forms of B-cell malignant blood diseases. These are patients with relapses and refractory forms, that is, resistant to therapy. These are thousands of patients with lymphomas and acute lymphoblastic leukemias, for whom there are virtually no other treatments. The clinical trial is designed for only 60 patients who will have to receive this therapy in the coming year, but it will open up new opportunities and give thousands upon thousands of patients a chance. The start of this clinical trial is extremely important, and we are looking forward to its results, said Olga Aleshina, Head of the Division of Cellular and Immune Therapy of the NMRC for Hematology, hematologist, chief researcher.

Utzhefra (nonproprietary name — hemagenlecleucel) is intended for the treatment of B-cell malignant neoplasms carrying the CD19 antigen on their surface. The studies will evaluate the tolerability, safety and efficacy of the drug in adult patients with relapses and refractory forms of the disease. The drug will be produced at its own licensed site of the NMRC for Hematology. In 2026, it is planned to complete the construction of a new full-cycle scientific and production complex for the creation of cellular medicines, which will significantly expand production volumes. 

In 2026, the National Medical Research Center for Hematology of the Ministry of Health of the Russian Federation will celebrate its 100th anniversary. In the same year, the commissioning of a new four-storey cell therapy building is scheduled. After completing clinical trials and passing all registration stages, we will be able to produce a CAR T-cell drug not only for our center, but also for other medical institutions across our country. From the first days of its establishment to the present, the NMRC for Hematology has been introducing unique developments into routine practice that make it possible for patients to be cured,” said Elena Parovichnikova, General Director of the NMRC for Hematology, chief freelance hematologist. 

Clinical trials will be completed by the end of 2025, followed by the registration of the drug. The Scientific Center for Advanced Interdisciplinary Research Idea helped to establish the technological process for the production of the cellular drug by providing equipment and consumables for scientific research. 

Clinical trials of Utzhefra are being implemented within the framework of the state task of the Ministry of Health of the Russian Federation. The start of these clinical trials became possible after the NMRC for Hematology received a license from the Ministry of Industry and Trade for the production of cellular gene therapy drugs in October 2024. This is the first clinical trial of a domestic CAR T-cell drug. 

Apollinaria Bogolyubova-Kuznetsova, Head of the Laboratory of Transplantation Immunology of the NMRC for Hematology, head of the CAR T therapy project:

Utzhefra was developed within the walls of the NMRC for Hematology and passed all stages of preclinical research, including the study of the effectiveness of the cellular drug using a line of superimmunodeficient mice at the Pavlov First State Medical University of St. Petersburg and the National Medical Research Center named after V. A. Almazov. Simultaneously, our team established the production of a cellular product, as well as developed and implemented a pharmaceutical quality system that ensures, first and foremost, the safety of the patient. Obtaining a license from the Ministry of Industry and Trade is the most important milestone on the drug's path to its use in therapy, as well as a sign of the quality of our work. Thus, as part of clinical trials, we are ready to provide patients with a high-quality, safe and effective CAR T-cell drug.” 

Related links: 

Completion of preclinical trials: https://blood.ru/about/novosti/v-nmits-gematologii-zaversheny-doklinicheskie-ispytaniya-sobstvennogo...  

Laying a time capsule in the foundation of the new building: https://blood.ru/about/novosti/vse-budushchee-zakladyvaetsya-v-nastoyashchem-/ 

Obtaining a license from the Ministry of Industry and Trade of Russia: https://blood.ru/en/about/news/the-nmrc-for-hematology-is-preparing-for-the-production-of-gene-thera... 

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