Инатикабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

DB18356

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor targeting CD19., The expressed transgene comprises a CD8α leader sequence, an anti-CD19 single chain variable fragment (scFv) derived from clone HI19a, a CD8α hinge and transmembrane region, and a 4-1BB and CD3ζ signalling 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, parts of the gag and env genes, a Rev response element (RRE), a central polypurine tract (cPPT) sequence, a Kozak sequence, and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 magnetic beads and transduced with the vector. The cells are then expanded in media supplemented with serum replacement and interleukin 2 (IL-2). The T lymphocytes (≥90%) are positive for the transgene (≥15% CAR positive), secrete interferon gamma, and demonstrate cytotoxicity against CD19 expressing cells

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