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MIVOCABTAGENE AUTOLEUCEL

UNII:QTE27WBS5A
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:MIVOCABTAGENE AUTOLEUCEL
GSRS Full Record:
QTE27WBS5A
i

  • Human autologous T cells expressing a next-generation chimeric antigen receptor (CAR) construct comprising a fully human single-chain variable fragment (scFv) targeting CD19 fused to co-stimulatory domains
  • KYV-101
  • MIVOCABTAGENE AUTOLEUCEL [USAN]
  • Mivocabtagene Autoleucel
  • autologous CD4+/CD8+ enriched T lymphocytes derived from leukapheresis material, transduced with a self-inactivating, non-replicating lentiviral vector encoding a CD19 targeting chimeric antigen receptor (CAR) comprising a CD8 alpha (CD8α) signal peptide, a single-chain variable fragment (scFv) derived from the human anti-CD19 monoclonal antibody clone 47G4, a CD8α hinge and transmembrane domain, a CD28 cytoplasmic co-stimulatory domain, and a CD3-zeta (CD3ζ) signaling domain, under control of the murine stem cell virus 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 /central termination sequence (CTS) and an optimised Woodchuck hepatitis virus posttranscriptional regulatory element. The vector is pseudotyped with vesicular stomatitis virus (VSV) 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 human serum, interleukin 7 (IL-7) and interleukin 5 (IL-5). The cells are then transduced with the lentiviral vector and expanded in growth media containing interleukin 7 (IL-7) and interleukin 5 (IL-5). The cell suspension consists of T lymphocytes (>80%), with greater than 10% of the T lymphocytes expressing the CAR-CD19 transgene. The transduced T lymphocytes demonstrate cytotoxicity against CD19-expressing cells and secrete interferon gamma (IFN-γ) and interleukin 2 (IL-2)
  • mivocabtagene autoleucel [INN]




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