Анзутресген аутолейцел

Prop. INN (наименование, предложенное ВОЗ)

autologous CD4+/CD8+ enriched T lymphocytes transduced with a self-inactivating, non-replicating lentiviral vector encoding a T cell receptor (TCR) specific for the preferentially expressed antigen in melanoma (PRAME).
The TCR transgene consists of a TCRα and a TCRβ chain separated by a self-cleaving ribosome skipping sequence derived from porcine teschovirus (P2A) under the control of a murine stem cell virus (MSCV) promoter and a Woodchuck hepatitis virus post-transcriptional response element (WPRE). The viral vector backbone also comprises a packaging signal ψ (psi), residual gag sequence, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS) and is flanked by 5' and 3' long terminal repeats (LTRs).
The vector is pseudotyped with vesicular stomatitis virus G glycoprotein.
The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 7 (IL-7) and interleukin 15 (IL-15).
The cells are then transduced with a lentiviral vector and expanded in growth media containing human AB serum, IL-7 and IL-15. The cell suspension consists of CD3+ T lymphocytes (≥90%) of which >20% of the CD3+CD8+ cells express the PRAME-specific TCR. The transduced T lymphocytes release interferon gamma (IFN-γ) by co- culture with PRAME-expressing tumor cells in vitro

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