The Russian Ministry of Health has approved phases I and II clinical trials for the CAR-T drug Utzhefra, developed by the National Medical Research Center of Hematology. The trials will assess its safety and efficacy in 60 adults with relapsed B-cell lymphoproliferative diseases, conducted until the end of 2025.
The developers will apply for drug registration after clinical trials. Only one CAR-T drug, Kimraya (tisagenlecleucel) by Novartis, is registered in Russia, approved in 2023 for treating specific cancers, costing around 39 million rubles.
The National Medical Research Center of Hematology plans to ensure production capacity of up to 600 units of the drug “Utzhefra” per year, while the total need for such drugs in Russia is estimated at approximately 10 thousand patients annually.