Варнимкабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

autologous T lymphocytes obtained from peripheral blood lymphocytes by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor targeting CD19., The expressed transgene comprises a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) derived from clone A3B1, a CD8α hinge and transmembrane region, and a 4-1BB (CD137) and CD3ζ (CD247) signalling domain and is under control of the elongation factor 1 alpha (EF1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence, a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and a remnant of a deleted nef gene.
The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the vector. The cells are then expanded in media supplemented with human AB serum from healthy male donors, interleukin (IL) 7 and IL-15. The cell suspension consists of T lymphocytes (>70%), with greater than 20% of the T lymphocytes expressing the CAR transgene, and cytotoxic potency is measured against a CD19+ leukemia cell line.

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