Тровокабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

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 (CAR) targeting human B cell maturation antigen (BCMA). The expressed transgene comprises a CD8α leader sequence, an anti-BCMA single chain variable fragment (scFv), a CD8α hinge and transmembrane domain, and a 4-1BB (CD137) and CD3ζ signal domain, under control of the human elongation factor 1α (EF-1α) short 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 a mutated Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The leukapheresis material is enriched for CD4/8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector before further culture and expansion in serum free growth media containing interleukin 2 (IL-2). The cell suspension consists of T lymphocytes (>90%; CD3+/CD45+), with ≥10% of the T lymphocytes expressing the CAR-BCMA transgene. The T lymphocytes secrete interferon gamma (IFN-γ) following co-culture with BCMA-expressing cells

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