FDA official logo
GSRS logoPFDA official logo

ZORPOCABTAGENE AUTOLEUCEL

UNII:WY5CN9QQ6T
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:ZORPOCABTAGENE AUTOLEUCEL
GSRS Full Record:

  • Zorpocabtagene Autoleucel
  • autologous T lymphocytes derived from peripheral blood cells transduced with a self-inactivating, non-replicating lentivirus vector encoding a chimeric antigen receptor (CAR) targeting CD19 comprising a leader sequence from granulocyte-macrophage colony-stimulating factor (GM-CSF) receptor subunit alpha, an anti-CD19 single chain variable fragment (scFv) derived from antibody FMC63, a CD8 hinge region, a tumour necrosis factor receptor superfamily member 19 (TNFRSF19) transmembrane domain (TM), a 4-1BB intracellular co-stimulatory domain and a CD3ζ signalling domain, under control of the elongation factor 1 alpha (EF-1α) promoter. The vector genome is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a viral packaging signal (Ψ), a truncated gag sequence, a Rev response element (RRE), a central polypurine tract/central termination sequence, and a unique synthetic qPCR ID tag sequence. The vector is pseudotyped with vesicular stomatitis virus envelope glycoprotein G (VSV G). The peripheral blood mononuclear cells (PBMC) are enriched for CD4+ and CD8+ T lymphocytes by immunoselection and activated with CD3 and CD28 agonists. The cells are then transduced with the lentiviral vector and expanded in growth media containing human AB serum, interleukin 7 (IL-7) and interleukin 15 (IL-15)
  • zorpocabtagene autoleucel [INN]



UNII - WY5CN9QQ6T | UNII Search Service