Samara State Medical University has become the first regional centre in Russia to receive approval to produce CAR‑T drugs, GxP News reports.
Samara State Medical University (SamSMU) has received permission from Russia’s Health Ministry to manufacture and use the biomedical cell product “Anti‑CD19 Human CAR-T Cells for Autologous Use”. The drug is intended for adult patients with refractory B-cell non-Hodgkin lymphomas who have received two or more lines of systemic therapy. SamSMU has become the first non‑capital centre in Russia to be granted such a licence. Production will be organised at the university.
“Today we have received the first permit in the history of SamSMU for the production and use of biomedical cell products. This is entirely our own Russian development – from the laboratory to the clinic,” said Alexander Kolsanov, rector of SamSMU and corresponding member of the Russian Academy of Sciences. He added that for the university this marks a new level of biomedical expertise, and for the country it means cell therapy independent of foreign suppliers.
The development was carried out with the support of the Moscow Centre for Innovative Technologies (Medtech). It provides a rapid response to tumour cells while virtually eliminating the risk of severe adverse reactions.
CAR‑T therapy is a personalised cell treatment in which a patient’s own immune cells are reprogrammed to fight cancer. It is one of the few methods that can lead to complete remission in certain haematological malignancies. According to the university’s estimates, implementation of the project will double overall survival for such patients and reduce dependence on expensive imports.
Earlier, SamSMU clinics already used NK-cell therapy in multiple myeloma patients, showing 80% efficacy with no serious adverse events. Hundreds of patients need such therapy each year. With the launch of domestic production, the university hopes treatment will become more accessible.
The first Russian CAR-T drug to receive approval was Utzhefra, developed by the National Medical Research Centre for Haematology for the treatment of B-cell blood cancers. The ministry approved its Phase I/II clinical trials in 2024. That same year, the centre received Russia’s first licence from the Industry and Trade Ministry to manufacture innovative CAR-T cell drugs.
In December 2025, the drug was administered to a human for the first time, and by the end of January 2026 the first patient had successfully completed her course of treatment, confirming the drug’s safety. Earlier this month, Tatiana Gaponova, first deputy director general of the National Medical Research Centre for Haematology, told GxP News that the centre plans to file for conditional registration of the drug as early as 2026.
