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FENCABTAGEN AUTOLEUCEL
FENCABTAGÉN AUTOLEUCEL
AUTOLOGOUS CD4/CD8 ENRICHED T LYMPHOCYTES OBTAINED FROM PERIPHERAL BLOOD BY LEUKAPHERESIS, TRANSDUCED WITH A SELFINACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR ENCODING A CHIMERIC ANTIGEN RECEPTOR TARGETING HUMAN RECEPTOR TYROSINE-PROTEIN KINASE ERBB-2 (ALSO KNOWN AS EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)). THE EXPRESSED TRANSGENE COMPRISES A HUMAN IMMUNOGLOBULIN G (IGG) LEADER SEQUENCE, AN EXTRACELLULAR HER2-BINDING DOMAIN PROVIDED BY A DESIGNED ANKYRIN REPEAT PROTEIN, A HUMAN C-MYC TAG SEQUENCE, AN ANTI-T CELL RECEPTOR (TCR)/CD3EPSILON BINDING DOMAIN PROVIDED BY THE HUMANIZED UCHT1 SINGLE-CHAIN ANTIBODY FRAGMENT (SCFV), AND A CD4 CO-RECEPTOR MEMBRANE ANCHORING AND INTRACELLULAR DOMAIN, UNDER THE CONTROL OF THE MURINE STEM CELL VIRUS (MSCV) PROMOTER. ... PROPOSED INN: LIST 129, RECOMMENDED INN: LIST 91