Замтокабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

Autologous T cells obtained from peripheral blood collected by leukapheresis, transduced with a nonreplicating lentiviral vector, pseudotyped with vesicular stomatitis virus (VSV) glycoprotein (G), encoding a codonoptimized chimeric antigen receptor (CAR) targeting the human B-lymphocyte antigens CD19 and CD20. Cells are activated in the presence of a colloidal polymeric nanomatrix covalently attached to anti-CD3 and anti-CD28, transduced, and then cultured in the presence of IL-7 and IL-15. The T cells are predominantly central memory (>80%; CD4+/CD8+, CD62L+, CD45RO+) and effector memory T cells (CD4+/CD8+, CD62L-, CD45RO+). The target binding moieties of the CAR are two single-chain variable fragments (scFv), derived from a murine antihuman CD20 and a murine anti-human CD19 hybridoma clone linked with a (GGGGS)₅ sequence, fused to intracellular signalling domains from 4-1BB and CD3 zeta, under the control of the elongation factor 1 alpha (EF1α) promoter. The genome also contains a 5' splice donor site and a 3' splice acceptor site, a gag truncated open reading frame, an env truncated open reading frame, a Rev response element (RRE) 5' to the transgene, a non-coding artificial sequence for viral titre determination and a nef truncated open reading frame 3' to the transgene.

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