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ZIPIDCABGENE AUTOLEUCEL

UNII:LV9G9H8D3J
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:ZIPIDCABGENE AUTOLEUCEL
GSRS Full Record:
LV9G9H8D3J
i

  • Zipidcabgene Autoleucel
  • autologous peripheral blood mononuclear cell (PBMC)-derived T lymphocytes obtained by leukapheresis, transduced with a self-inactivating non-replicating lentiviral vector encoding a looped bispecific chimeric antigen receptor (CAR) targeting both CD19 and B cell maturation antigen (BCMA), comprising a CD8 leader sequence, an anti-CD19 single-chain variable fragment (scFv) (derived from clone FMC63) plus an anti-BCMA scFv, linked to one CD8 hinge and transmembrane region, followed by a 4-1BB co-stimulatory domain and a CD3ζ intracellular signal transduction domain, under control of an elongation factor 1 alpha (EF-1α) promoter and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The vector genome also contains an HIV-1 packaging signal (ψ), a Rev response element (RRE), a central polypurine tract (cPPT)/central termination sequence (CTS) and is flanked by 5' and 3' long terminal repeats (LTRs). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists 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 and human serum albumin. The cell suspension consists of T lymphocytes (≥70%), with ≥5% of the T lymphocytes expressing the CD19/BCMA CAR transgene.
  • zipidcabgene autoleucel [INN]




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