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Utzhefra is a novel CAR T-cell drug developed by the National Medical Research Center for Hematology in Russia. It is designed for the treatment of B-cell malignant neoplasms, specifically targeting relapsed and refractory forms of B-cell malignant blood tumors, including lymphomas and acute lymphoblastic leukemias. The drug functions by genetically modifying a patient's own T-lymphocytes using a viral vector to express a chimeric antigen receptor (CAR) that recognizes the CD19 antigen present on the surface of these cancerous B-cells. This CAR T-cell therapy aims to harness the patient's immune system to identify and eliminate cancer cells. Clinical trials for Utzhefra (Phase I and II) commenced in December 2024, with an anticipated completion by the end of 2025, after which regulatory submission for registration is planned.
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