Итезокабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

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 CD3ζ 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+ (≥70%; historically 98% +/- 1.7%), anti-CD30-CAR (≥20%), are cytotoxic for CD30-expressing cells and contain <1% of residual B and natural killer (NK) cells.

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