Russia’s National Medical Research Centre for Haematology has completed a Phase I/II clinical trial of Utzhefra (gemagenlecleucel), the first Russian anti-CD19 CAR-T cell drug for treating B‑cell blood cancers. In 2026, the centre plans to submit documents for conditional registration of the drug, it said in response to an official inquiry from GxP News.
“The Phase I/II clinical trial has been completed, and a report has been sent to the Ministry of Health of the Russian Federation,” said Tatiana Gaponova, first deputy director general of the centre, in a letter. “Given the orphan status of the indications (B-cell blood cancers), a dossier for conditional registration of the drug based on the results of the first phases of clinical trials is planned for submission in 2026.”
The centre added that the clinical trial evaluating long-term response to therapy has not yet been completed.
Conditional registration allows a drug to reach the market before full clinical trials are completed – for vital medicines with high benefit and no alternatives. Standard registration is only possible after a full trial cycle.
It became known in 2024 that the Health Ministry had approved Phase I/II clinical trials of Utzhefra. 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, following successful tests in mice, the drug was administered to a human for the first time. By the end of January this year, the centre reported that the first patient had successfully completed her course of treatment and confirmed the drug’s safety. A total of 60 patients were planned to be enrolled in the study.
In April this year, centre director Elena Parovichnikova, a corresponding member of the Russian Academy of Sciences, also noted that the drug would be free for patients under the state guarantees programme. Around the same time, Prime Minister Mikhail Mishustin announced that the government had added CAR-T therapy to the compulsory health insurance programme. Previously, such technologies were available only through research studies or on a commercial basis. The move will expand patient access to these treatments.
Currently, only one CAR-T drug is registered in Russia – Novartis’s Kymriah (tisagenlecleucel), used to treat acute lymphoblastic leukaemia and refractory diffuse large B-cell lymphoma. It is one of the most expensive drugs: according to the latest data from analytics firm Cursor, its price in the first quarter of 2026 was 28.3 million roubles per pack.
