Эквекабтаген 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 1 alpha (EF-1α) 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 an optimized Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G.
The leukapheresis material is enriched for CD3+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector before further culture and expansion in growth media containing interleukin 2 (IL-2). The cell suspension consists of T lymphocytes (>90%), with greater than 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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