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TALICABTAGENE AUTOLEUCEL

UNII:FB64K38TE2
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:TALICABTAGENE AUTOLEUCEL
GSRS Full Record:
FB64K38TE2
i

  • Talicabtagene Autoleucel
  • autologous peripheral blood mononuclear cells (PBMCs) obtained by leukapheresis enriched for CD3+ T lymphocytes, transduced with a self-inactivating non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19, comprising a CD8α leader sequence, a humanised anti-CD19 single chain variable fragment (scFv; derived from the FMC63 antibody), human CD8α hinge and transmembrane domain, human 4-1BB co-stimulatory domain and human CD3ζ signalling domain, under control of the elongation factor-1 alpha (EF-1α) promoter. 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 CD3+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media supplemented with human AB serum and interleukin 2 (IL-2). The T lymphocytes (≥95%) are positive for the transgene (≥15% CAR positive) and are cytotoxic (≥50%) when co-cultured with CD19 expressing tumour cell lines
  • talicabtagene autoleucel [INN]




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