RESECABTAGENE AUTOLEUCEL

UNII:	DS272D3LHY
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	RESECABTAGENE AUTOLEUCEL
GSRS Full Record:	DS272D3LHY i

Autologous T lymphocytes derived from peripheral blood mononuclear cells obtained by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19. The expressed transgene comprises a CD8α signal peptide, a fully human anti-CD19 single chain variable fragment (scFv) (clone IC78), a CD8α hinge and transmembrane region, and a 4-1BB co-stimulatory domain and CD3ζ signaling domain, under control of the elongation factor-1 alpha (EF-1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains an HIV-1 ψ packaging signal, part of the HIV-1 gag and env genes, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS), a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and the nef gene. The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G.
RESECABTAGENE AUTOLEUCEL [USAN]
Resecabtagene Autoleucel
autologous T lymphocytes derived from peripheral blood mononuclear cells obtained by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19. The expressed transgene comprises a CD8α signal peptide, an anti-CD19 humanised single chain variable fragment (scFv) (clone IC78), a CD8α hinge and transmembrane region, and a 4-1BB co-stimulatory domain and CD3ζ signaling domain, under control of the elongation factor-1 alpha (EF-1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains an HIV-1 ψ packaging signal, part of the HIV-1 gag and env genes, a Rev response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS), a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and the nef gene. The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The leukapheresis material is enriched for CD4+/CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media supplemented with serum replacement and interleukin 2 (IL-2). The cell suspension consists of T lymphocytes (≥80%) with greater than 10% of the T lymphocytes expressing the CAR transgene, other cell types (expressing CD16, CD14 and CD19) are present at ≤20%, and memory T lymphocyte subsets are phenotypically determined. The cells exhibit cytotoxicity towards CD19 expressing B lymphocytes upon co-culture
resecabtagene autoleucel [INN]

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UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

RESECABTAGENE AUTOLEUCEL

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