FDA official logo
GSRS logoPFDA official logo

ROMUCABTAGENE AUTOLEUCEL

UNII:S2H6M754GZ
Type:INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:ROMUCABTAGENE AUTOLEUCEL
GSRS Full Record:
S2H6M754GZ
i

  • Romucabtagene Autoleucel
  • autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a non-replicating gamma-retroviral vector derived from myeloproliferative sarcoma virus and murine embryonic stem cell virus, encoding a chimeric antigen receptor (CAR) targeting the B-cell maturation antigen (BCMA; TNFRSF17, CD269) and a truncated human epidermal growth factor receptor (tEGFR) separated from the CAR by a P2A self-cleaving peptide sequence derived from porcine teschovirus type 1. The expressed transgene comprises a CD8α signal peptide, an anti-BCMA single chain variable fragment (scFv) derived from clone C11D5.3, a CD8α hinge, a CD8α transmembrane region, a 4-1BB co-stimulatory domain and a CD3ζ signalling domain. The tEGFR is preceded by a granulocyte macrophage colony-stimulating factor receptor (GM-CSFR) signal peptide. The construct is flanked by 5' and 3' long terminal repeats (LTRs), which control transcription and polyadenylation respectively, and contains a psi (Ψ) packaging signal. The vector is pseudotyped with the gibbon ape leukaemia virus (GALV) envelope (Env) glycoprotein. The peripheral blood mononuclear cells (PBMC) are selected and activated with anti-CD3 / anti-CD28 agonistic antibodies in growth media containing interleukin 2 (IL-2). The cells are then transduced with the retroviral viral vector and further expanded in growth medium containing IL-2. The T lymphocytes (≥95%) are positive for the transgene (≥15% CAR positive), and express CD107a (≥20%) after co-incubation with BCMA+ target cells. In addition, the cells demonstrate cytotoxicity against BCMA expressing cells and secrete interferon gamma (IFN-γ) and IL-2
  • romucabtagene autoleucel [INN]




UNII - S2H6M754GZ | UNII Search Service