NSU opens laboratory to create reagents for CAR-T therapy

The head of the scientific division is candidate of biological sciences Sergey Kulemzin. The new direction of research will be developed on the basis of the infrastructure of the world-class campus of NSU, the laboratory is located in the research center of the university.

The laboratory will develop a new domestic diagnostic reagent designed to detect CD19-specific CAR T cells. This reagent is a recombinant protein that will be produced in eukaryotic cells with subsequent purification by chromatography. Its use will allow monitoring the quality of CAR T products before administration to the patient, as well as monitoring the dynamics of CAR T cell expansion in the peripheral blood during therapy.

At the moment, only one cell drug is registered in Russia – Kimraya (tisagenlecleucel) from the Swiss Novartis. The therapy was approved by the Ministry of Health in 2023 for the treatment of acute lymphoblastic leukemia and refractory diffuse large B-cell lymphoma. The regulator then announced that it would review the risk-benefit ratio of Kimraya until the clinical trials are completed and Novartis presents final conclusions on the efficacy and safety of the drug. The cost of one course of CAR-T from the Swiss manufacturer was estimated at 39 million rubles.

In January 2025, the National Medical Research Center of Hematology reported the results of the first stage of treatment of a participant in clinical trials of Utzhefra, a domestic cellular gene therapy drug for the treatment of malignant blood tumors. According to the research center, the patient successfully completed phase I of the clinical trial and switched to outpatient treatment to evaluate the long-term performance of the CAR-T drug. The institution received permission for the Utzhefra clinical trial in November 2024, and its completion is scheduled for the end of 2025.