Далукабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

autologous T cells obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a replication incompetent Moloney murine leukemia virus (MoMLV)-based retroviral vector, encoding two T cell chimeric antigen receptors (CARs) targeting CD19 and CD22, separated by a 2A self-cleaving peptide derived from the Thosea asigna virus capsid protein, under control of a MoMLV-based promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs), and contains a ψ packaging signal and the scaffold/matrix attachment region (S/MAR) from the human β interferon gene.
The cells are activated using an anti-CD3/CD28 reagent in medium supplemented with human AB serum, interleukin 7 (IL-7) and 15 (IL-15). Activated cells are incubated with the vector before further culture expansion. The CAR positive T cells are predominantly CD4/CD8, and secrete granzyme B, interferon gamma, tumour necrosis factor alpha (TNF-α) and interleukin-2 (IL-2) after co-culture with a cell line expressing the CD19 and CD22 antigen.

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