Ольмокабтаген аутолейцел

Prop. INN (наименование, предложенное ВОЗ)

autologous CD4+/CD8+ enriched T lymphocytes obtained by leukapheresis, transduced with a self-inactivating, non- replicating gamma Moloney murine leukemia virus (MMLV) vector encoding a chimeric antigen receptor (CAR) targeting claudin 6 (CLDN6), composed of a human IgG heavy chain signal peptide, a single chain variable fragment (scFv; IMAB206-C46S), a CD8 hinge and transmembrane domain, and a 4-1BB co-stimulatory and CD3ζ intracellular signalling domain, under control of the elongation factor 1 alpha short (EFS) promoter. The vector also contains an MMLV psi- region, an enlarged MMLV psi+ packaging region, a Kozak sequence, and a truncated version of the post- transcriptional regulatory element of the Woodchuck hepatitis virus (WPRE); flanked by 5' and 3' MMLV wildtype long terminal repeats (LTRs). The vector is pseudotyped with gibbon ape leukemia virus (GALV) envelope protein.
The leukapheresis material is enriched for CD4+/CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the retroviral vector. The cells are then expanded in media with interleukin 15 (IL-15) and interleukin 7 (IL-7). The T lymphocytes (≥80%; with ≤20% CD3- cells) are positive for the transgene (≥10% CAR positive) and secrete interferon gamma in response to CLDN6 expressing target cells

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