SENACNAGENE ENFALEUCEL

UNII:	WHJ747UHJ8
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	SENACNAGENE ENFALEUCEL
GSRS Full Record:	WHJ747UHJ8 i

Senacnagene Enfaleucel
allogeneic natural killer (NK) cells derived from peripheral blood mononuclear cells (PBMC) obtained by leukapheresis from healthy donors, transduced with a replication deficient murine stem cell virus (MSCV) derived γ-retroviral vector encoding (i) an activating chimeric receptor (ACR) composed of a CD8α signal peptide, the extracellular domain of the natural killer group 2, member D (NKG2D) receptor (also known as killer cell lectin-like receptor K1 (KLRK1)), fused to a CD8α transmembrane domain, an OX40 costimulatory domain and a CD3ζ signalling domain, and (ii) interleukin-15 (IL-15) preceded by a CD8α signal peptide and fused to a CD8α hinge and transmembrane domain, which creates a membrane bound form of IL-15 (mbIL-15), separated by a self-cleaving T2A peptide. The vector is pseudotyped with RD-114 virus envelope glycoprotein. The CD56+ CD3- NK cells are isolated by leukapheresis and cocultured with a modified and irradiated K562 cell line
senacnagene enfaleucel [INN]

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UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

SENACNAGENE ENFALEUCEL

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