Зеворкабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

autologous T cells obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor (CAR) targeting B-cell maturation antigen (BCMA, TNFRSF17, CD269). The expressed transgene comprises the antiBCMA single-chain variable fragment (scFv), a CD8α hinge and transmembrane (TM) domain, a 4-1BB costimulatory domain, a CD3ζ domain and is under control of the elongation factor 1 alpha (EF1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The T cells are cultured in the presence of growth medium containing IL-2 and activated using anti-CD3 and anti-CD28 antibodies. The cell suspension consists of T cells (>70%), natural killer (NK) cells and low numbers of non-T cells. Greater than 10% of the T cells express the CARBCMA transgene. The T cells secrete interferon gamma (IFN-γ) following co-culture with BCMAexpressing cells.

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