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EMICABTAGENE LEUCEL

UNII:N952MJE48Y
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:EMICABTAGENE LEUCEL
GSRS Full Record:
N952MJE48Y
i

  • Emicabtagene Leucel
  • allogeneic CD4+ and CD8+ T lymphocytes derived from a patient's prior allogeneic hematopoietic stem cell transplantation donor, transduced with a self-inactivating, non-replicating (SIN) lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD33 (also known as sialic acid binding Ig-like lectin 3, Siglec-3) comprising a human CD8alpha leader sequence, a humanised anti-CD33 single chain variable fragment (scFv; derived from lintuzumab, clone huM195), a CD28 hinge region, CD28 transmembrane and co-stimulatory domain, and an intracellular signal transduction domain (CD3ζ), under control of the human elongation factor 1 alpha (EF-1α) promoter and Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a packaging signal, truncated gag, a Rev response element (RRE), an envelope glycoprotein 41 (gp41) peptide, a central polypurine tract/central termination sequence (cPPT/CTS) 5' to the transgene, and a partial nef/polypurine tract (PPT) sequence 3' to the transgene. The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The apheresis material collected from a patient's prior stem cell donor is enriched for CD4+/CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are expanded in media containing human AB serum and interleukin 2 (IL-2). The T lymphocytes (>94% CD3+) are positive for the transgene (>20% CAR positive), demonstrate cytotoxicity against CD33-expressing cells, and secrete interferon gamma in response to co-culture with CD33-expressing tumour cell lines
  • emicabtagene leucel [INN]




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