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ATLACABTAGENE AUTOLEUCEL

UNII:UPD257SDU9
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:ATLACABTAGENE AUTOLEUCEL
GSRS Full Record:
UPD257SDU9
i

  • Atlacabtagene Autoleucel
  • atlacabtagene autoleucel [INN]
  • autologous T lymphocytes obtained from peripheral blood mononuclear cells, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human B-lymphocyte antigen CD19. The expressed transgene comprises a granulocyte-macrophage colony-stimulating factor receptor(GM-CSFR) leader sequence, an anti-CD19 single-chain variable fragment (scFv) (derived from antibody FMC63), a CD28 hinge, a CD28 transmembrane and endodomain, the Toll/interleukin-1 receptor (TIR) domain of the Toll-like receptor 2 (TLR-2) and a CD3ζ signalling domain, under control of the human elongation factor 1α (EF-1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and contains a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and a mutated Woodchuck hepatitis virus post transcriptional element (WPRE). 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 interleukin 2 (IL-2). The T lymphocytes (≥80% CD3+ cells; with ≤1% CD3-CD19+ and ≤1% CD3-CD22+ B lymphocytes), are positive for the transgene (≥5% CAR+), and after co-incubation with CD19-expressing target cells demonstrate interferon gamma (IFN-γ) secretion




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