OSENCABTAGENE AUTOLEUCEL
UNII XUA5T4H9TM

Substance Identification & Data

This profile provides standardized clinical and technical data for Osencabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) XUA5T4H9TM.

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.

FDA UNII Code

XUA5T4H9TM

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

OSENCABTAGENE AUTOLEUCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C207225

National Cancer Institute reference terminology for clinical and research data.

INN ID

13044

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Osencabtagene 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 Osencabtagene 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

Osencabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood by leukapheresis, transduced with two self-inactivating, nonreplicating lentiviral vectors encoding: (i) a chimeric antigen receptor (CAR) targeting human CD7: the expressed transgene comprises a granulocyte-macrophage colony-stimulating factor (GM-CSF) receptor signal sequence, a single-domain antibody derived from a humanized nanoantibody (HuVHH6) targeting CD7, an immunoglobulin G4 (IgG4) Fc hinge, an inducible T lymphocyte costimulator (ICOS) transmembrane and intracellular domain, a 4-1BB intracellular costimulatory domain and a CD3ζ intracellular activation domain, under control of the human elongation factor 1 alpha (EF1α) promoter. (ii) a CD7-blocking gene comprising a granulocyte-macrophage colonystimulating factor (GM-CSF) receptor signal sequence, a bivalent CD7 nano-antibody sequence (VHH6-linker-VHH6) fused to an endoplasmic reticulum (ER) retention sequence (KDEL sequence), under control of the cytomegalovirus promoter. In both constructs, the transgene is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a Rev response element (RRE) and a central polypurine tract (cPPT) sequence 5' to the transgene, and a Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE)3' to the transgene. Both vectors are pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 7 (IL-7) and interleukin 15 (IL-15). The cells are then transduced with the lentiviral vectors and expanded in growth media containing IL-7 and IL-15. The cell suspension consists of CD3+ T lymphocytes (≥90%; of which CD3+CD7- T lymphocytes account for more than 95%), with greater than 5% of the T lymphocytes expressing the CAR transgene

osencabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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