Релмакабтаген аутолейцел

Rec. INN (наименование, зарегистрированное ВОЗ)

Autologous CD4+ and CD8+ enriched T cells transduced ex vivo with a self-inactivating lentivirus vector encoding an anti-CD19 chimeric antigen receptor.
Autologous CD4+ and CD8+ T cells, enriched from peripheral blood mononuclear cells (PBMCs) transduced with a non-replicative self-inactivating (SIN) lentiviral vector encoding a chimeric antigen receptor (CAR) consisting of the human CD19-specific scFv, an lgG4 hinge region, CD28 transmembrane domain, CD137 (4-1BB) co-stimulatory domain and CD3 zeta signalling domain, under the control of a hybrid Elongation Factor 1 alpha (EF1α) and Human T cell Leukemia Virus type 1 (HTLV-1) regulatory element promoter and woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector genome also encodes a truncated human epidermal growth factor receptor (EGFRt) that is co-expressed with the CAR and cleaved from it by the T2A selfcleaving peptide. The vector genome also contains a splice donor, a fragment of gag, a Rev response element (RRE), a mutated central polypurine tract (cPPT), and a splice acceptor.

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