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OBECABTAGENE AUTOLEUCEL

  • UNII: 760HJB0YRD
  • Preferred Substance Name: OBECABTAGENE AUTOLEUCEL

  • AUTO1
  • AUTO-1
  • AUTOLOGOUS CD4+ AND CD8+ T CELLS, ENRICHED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMCS) OBTAINED BY APHERESIS TRANSDUCED EX VIVO WITH A NON-REPLICATING, SELF-INACTIVATING (SIN) LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) CONSISTING OF AN ANTI-CD19 SPECIFIC SCFV, A CD8.ALPHA. STALK, TRANSMEMBRANE DOMAIN AND ANCHOR, A 41BB ENDODOMAIN AND A CD3 ZETA ENDODOMAIN, UNDER THE CONTROL OF A HUMAN PGK1 PROMOTER AND A MODIFIED WOODCHUCK POST TRANSCRIPTIONAL RESPONSE ELEMENT. THE VECTOR GENOME ALSO CONTAINS A 5' TERMINAL CMV ENHANCER/PROMOTER, A .PSI. PACKAGING SIGNAL, A REV RESPONSE ELEMENT (RRE) AND A CENTRAL POLYPURINE TRACT (CPPT)
  • OBECABTAGENE AUTOLEUCEL [INN]
  • OBECABTAGENE AUTOLEUCEL [USAN]
  • OBECABTAGENE AUTOLEUCEL [WHO-DD]
  • SELF-INACTIVATING LENTIVIRAL VECTOR CONSISTING OF 5' FUSION BETWEEN THE CMV PROMOTER AND HIV LTR, WHERE THE CMV PROMOTER REPLACES THE U3 REGION. PACKAGING SIGNAL (.PSI.), THE REV RESPONSIVE ELEMENT (RRE) AND THE CENTRAL POLYPURINE TRACT (CPPT) ARE RETAINED. EXPRESSION IS DRIVEN BY THE HUMAN PGK1 PROMOTER, AND EXPRESSION IS ENHANCED BY A MODIFIED WOODCHUCK POST TRANSCRIPTIONAL RESPONSE ELEMENT (MWPRE)

Note

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.