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RAPCABTAGÉN AUTOLEUCEL
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A SELF-INACTIVATING, NONREPLICATING LENTIVIRAL VECTOR, ENCODING A T CELL CHIMERIC ANTIGEN RECEPTOR TARGETING CD19. THE EXPRESSED TRANSGENE COMPRISES A CD8ALPHA LEADER SEQUENCE, A MURINE ANTI-CD19 SINGLE CHAIN VARIABLE FRAGMENT (SCFV) DERIVED FROM THE MOUSE HYBRIDOMA FMC63, A CD8ALPHA HINGE AND TRANSMEMBRANE REGION, AND A 4-1BB (CD137) AND CD3ZETA (TCRZETA) SIGNALING DOMAIN AND IS UNDER CONTROL OF THE ELONGATION FACTOR 1 ALPHA (EF1ALPHA) PROMOTER. THE CONSTRUCT IS FLANKED BY 5' AND 3' LONG TERMINAL REPEATS (LTRS) AND ALSO CONTAINS A PSI PACKAGING SIGNAL, A REV RESPONSE ELEMENT (RRE), A CENTRAL POLYPURINE TRACT (CPPT) SEQUENCE AND AN OPTIMIZED WOODCHUCK HEPATITIS VIRUS POSTTRANSCRIPTIONAL REGULATORY ELEMENT (WPRE)...; PROPOSED INN: LIST 126