Раникабтаген аутолейцел

Prop. INN (наименование, предложенное ВОЗ)

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a non- replicating gamma-retroviral vector, encoding a chimeric antigen receptor targeting CD19, comprising a CD8α signal peptide, an anti-CD19 single chain variable fragment (scFv) (derived from clone FMC63), a CD8α hinge, a CD28 transmembrane region, an intracellular CD28 co-stimulatory and a CD3ζ signalling domain., The construct is flanked by 5' and 3' long terminal repeats (LTRs), derived from the myeloproliferative sarcoma virus (MPSV) and the murine embryonic stem cell virus (MESV), which contain a 5' LTR promoter and 3' LTR termination sequence. The vector also contains a psi packaging signal and is pseudotyped with gibbon ape leukemia virus (GALV) Env glycoprotein.
The leukapheresis material is enriched for CD3+ T lymphocytes by positive immunoselection, prior to activation with CD3 and CD28 agonists. The cells are then transduced with the retroviral vector and expanded in media containing interleukin 2 (IL-2). The T lymphocytes (≥ 90%) are positive for the transgene (≥20% CAR positive), express CD107a (≥20%) and demonstrate cytotoxicity towards CD19 expressing cells

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