Ситокабнаген локсивелеуцел

Rec. INN (наименование, зарегистрированное ВОЗ)

allogeneic natural killer (NK) cells derived from umbilical cord blood, transduced with a Moloney murine leukaemia virus (MMLV)-based retroviral vector encoding inducible caspase-9 comprising human caspase-9 fused to a human FK506 binding protein variant (FKBP-F36V), a chimeric antigen receptor (CAR) targeting CD19 fused to CD28 and CD3 zeta signalling domains, and secretable human interleukin 15 (IL-15), linked together by T2A and E2A self-cleaving peptide sequences, respectively, under the control of the 5' long terminal repeat (LTR) MMLV promoter; the construct is flanked by 5' and 3' LTRs and contains an MMLV ψ packaging signal and partial pol gene. The vector is pseudotyped with the envelope glycoprotein of gibbon ape leukaemia virus (GaLV).
The cord blood mononuclear cells are treated with antibody-coated magnetic beads against CD19, CD3 and CD14 to remove B cells, T cells, and monocytes.
The purified NK cells are then activated using an irradiated antigen presenting cell line (APC) in the presence of growth medium containing IL-2. Further depletion of residual CD3+ T cell may be performed using antibody-coated magnetic beads. The substance contains >80% NK cells (CD45+CD3-CD56+), of which with >21% are CAR positive, and secrete IL-15.

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