RESECABTAGENE AUTOLEUCEL
UNII DS272D3LHY
Substance Identification & Data
This profile provides standardized clinical and technical data for Resecabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) DS272D3LHY.
Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.
DS272D3LHY
N/A
N/A
Detailed Substance Profile
Preferred Name
RESECABTAGENE AUTOLEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
National Cancer Institute reference terminology for clinical and research data.
INN ID
13279
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
OP-108
Identifier assigned by the United States Adopted Names Council.
Substance Type
Resecabtagene Autoleucel
ISO 11238 classification category (e.g., Chemical, Polymer, Protein).
ITIS TSN
180092
Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.
NCBI Taxonomy
9606
Unique numeric identifier used to specify biological species in the NCBI database.
Synonyms and Nomenclature
This section provides a complete list of nomenclature and identifier mappings for Resecabtagene Autoleucel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.
FDA Official Name
Resecabtagene Autoleucel
Common Names & Synonyms
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]
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]
