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ITEZOCABTAGÉN AUTOLEUCEL
ITÉZOCABTAGENE AUTOLEUCEL
AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A NON-REPLICATING MOLONEY MURINE LEUKAEMIA VIRUS (MMLV) VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) UNDER THE CONTROL OF THE 5' LONG TERMINAL REPEAT (LTR) MMLV PROMOTER, COMPRISING A SINGLE-CHAIN VARIABLE FRAGMENT DERIVED FROM THE MURINE ANTIBODY HRS3 TARGETING CD30 (TUMOUR NECROSIS FACTOR RECEPTOR SUPERFAMILY MEMBER 8 [TNFRSF8]), AN IGG1 CH2-CH3 SPACER, CD28 TRANSMEMBRANE AND INTRACELLULAR COSTIMULATORY DOMAINS, AND A CD3ZETA INTRACELLULAR ACTIVATION DOMAIN. THE T CELLS ARE ACTIVATED IN THE PRESENCE OF ANTI-CD3 AND ANTI-CD28 THEN CULTURED IN THE PRESENCE OF GROWTH MEDIUM CONTAINING HUMAN SERUM, INTERLEUKIN 7 (IL-7) AND IL-15. THE T CELLS ARE CD3+ (MORE OR EQUAL TO 70%; HISTORICALLY 98% +/- 1.7%), ANTI-CD30- CAR (MORE OR EQUAL TO 20%), ARE CYTOTOXIC FOR CD30-EXPRESSING CELLS AND CONTAIN <1% OF RESIDUAL B AND NATURAL KILLER (NK) CELLS