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PLIXACABTAGÉN AUTOLEUCEL
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A SELF-INACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING CD19. THE EXPRESSED TRANSGENE COMPRISES A GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR RECEPTOR SUBUNIT ALPHA (CSF2RA) SIGNAL PEPTIDE, A MURINE ANTI-CD19 SINGLE CHAIN VARIABLE FRAGMENT (SCFV) DERIVED FROM MOUSE HYBRIDOMA FMC63, CONSISTING OF A VARIABLE LIGHT CHAIN (VL), A 15 AMINO ACID FLEXIBLE GLYCINE/SERINE SPACER (G4S)3, AND A VARIABLE HEAVY-CHAIN (VH), FOLLOWED BY A SHORT LINKER SEQUENCE AND THE INVARIANT HUMAN CD3EPSILON TCR SUBUNIT CODING SEQUENCE, AND IS UNDER CONTROL OF THE ELONGATION FACTOR 1 ALPHA (EF1ALPHA) PROMOTER...; PROPOSED INN: LIST 126