EDELTRESGENE AUTOGELEUCEL
UNII 9X4N9B4MMT

Substance Identification & Data

This profile provides standardized clinical and technical data for Edeltresgene Autogeleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 9X4N9B4MMT.

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
9X4N9B4MMT
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
EDELTRESGENE AUTOGELEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
INN ID
14018
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
Edeltresgene Autogeleucel
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 Edeltresgene Autogeleucel. 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

Edeltresgene Autogeleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood via leukapheresis, electroporated with three CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9) /guide RNA (gRNA) nucleoprotein complexes to disrupt the T cell receptor alpha chain constant (TRAC), the T cell receptor beta constant (TRBC) 1 and 2, and the TGF-beta receptor type-2 (TGFBR2) loci. At the same time, the cells are electroporated with linear, closed-end, double-stranded DNA (lc-dsDNA), encoding an HLA-A*02:01-restricted T cell receptor (TCR) targeting cellular tumour antigen p53 (TP53) variant R175H, which leads to site-specific integration of the dsDNA at the TRAC locus via homologous recombination. The TCR transgene consists of TCRβ and TCRα chains separated by self-cleaving 2A peptide sequences and by a modified dihydrofolate reductase (DHFR). The apheresis material is enriched via immunomagnetic selection of CD4 and CD8 expressing cells and activated using anti-CD3 and anti-CD28 antibodies in growth media containing recombinant cytokines interleukin 7 (IL-7) and IL-15. The cells are then electroporated with the constructs before further expansion in media containing IL-7 and IL-15. During culture, the cells also undergo an enrichment of transgene positive T lymphocytes via chemoselection with methotrexate (MTX). The T lymphocytes (sum of CD4 + plus CD8 + ≥80%) are enriched for CD8 + cells, with subsets of T helper lymphocytes (CD4 + ). The CD4 + subset is predominately composed of CD27 + CD28 + and CD45RA - CCR7 - populations, whereas the CD8 + subset is a mixture of CD27 + CD28 + , CD45RA -CCR7 - , CD45RA + CCR7 - , and CD45RA + CD62L + populations. The transgene (neoantigen specific TCR) expression in the final substance is ≥40%, and the knock-out efficiencies for TRAC, TRBC and TGFBR2 are measured by digital PCR. Following co-culture of the T lymphocytes with tumour target cell lines the lymphocytes proliferate, are cytotoxic and secrete interferon gamma (IFN-γ) and IL-2 in response to antigen stimulation
edeltresgene autogeleucel [INN]

External Clinical & Regulatory Resources

NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record