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BELACABNAGENE FRANLEUCEL

UNII:JG828PW4NT
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:BELACABNAGENE FRANLEUCEL
GSRS Full Record:
JG828PW4NT
i

  • BELACABNAGENE FRANLEUCEL [USAN]
  • Belacabnagene Franleucel
  • Human peripheral blood mononuclear cell (PBMC)-derived natural killer (NK) cells transduced with viral vector encoding a CD19-targeting chimeric antigen receptor (CAR) and membrane bound interleukin-15 (mbIL-15)
  • NKX 019 [WHO-DD]
  • NKX-019
  • NKX019
  • allogeneic natural killer (NK) cells obtained from peripheral blood mononuclear cells (PBMC) by leukapheresis, transduced with a non-replicating gamma (γ)-retroviral vector encoding a chimeric antigen receptor (CAR) targeting CD19 together with a membrane bound form of human interleukin-15 (mbIL15). The expressed transgene comprises a CD8 alpha (CD8α) leader sequence, a humanized anti-CD19 single-chain variable fragment derived from murine FMC63, a CD8α transmembrane domain, an OX40 costimulatory domain, and a CD3ζ signalling domain, separated by a self-cleaving T2A peptide from IL-15 fused to a CD8α transmembrane domain, which creates a membrane bound form of IL-15 (mbIL-15) under control of a promoter derived from the U3 region of the murine stem cell virus (MSCV) 5' long terminal repeat (LTR). The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a murine embryonic stem cell virus packaging signal. The CD56+ CD3- NK cells are isolated by leukapheresis and cocultured with a modified and irradiated K562 cell line. Specifically, the NK cells are isolated through a series of steps, first to reduce platelets and red blood cells, followed by a CD3+ depletion step, and lastly a positive selection using CD56+ enrichment. The cells are cultured in serum replacement media containing interleukin-12 (IL-12), interleukin-18 (IL-18) and interleukin-2 (IL-2) and co-cultured with a modified and irradiated K562 cell line. The cells are then transduced with the retroviral vector, and the transduced NK cells are further expanded in media containing human AB serum and IL-2
  • belacabnagene franleucel [INN]




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