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DICOCABTAGENE AUTOLEUCEL

UNII:Y8HFK62WVL
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:DICOCABTAGENE AUTOLEUCEL
GSRS Full Record:
Y8HFK62WVL
i

  • Dicocabtagene Autoleucel
  • Dicocabtagene autoleucel [INN]
  • autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a CD19-specific chimeric antigen receptor (CAR) comprising a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) (derived from the mouse hybridoma FMC63), a CD8α hinge and transmembrane domain, an intracellular 4-1BB (CD137) co-stimulatory domain and a CD3ζ signalling domain and is under control of the elongation factor 1 alpha (EF-1α) core promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a human immunodeficiency virus 1 (HIV-1) ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) and central termination sequence (CTS) and a mutated Woodchuck hepatitis virus post transcriptional regulatory element (WPRE mut6). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The peripheral blood mononuclear cells (PBMC) are selected and activated with anti-CD3/anti-CD28 agonistic antibodies in growth media containing interleukin 2 (IL-2). The cells are then transduced with the lentiviral vector and expanded in growth media containing IL-2. The T lymphocytes (≥90%) are positive for the transgene (≥5% CAR+), and after co-incubation with CD19-expressing target cells demonstrate cytotoxicity and secrete interferon gamma (IFN-γ) and IL-2




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