ELZOCABTAGENE AUTOLEUCEL
UNII T2ZFF62NQ9

Substance Identification & Data

This profile provides standardized clinical and technical data for Elzocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) T2ZFF62NQ9.

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

T2ZFF62NQ9

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ELZOCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C211708

National Cancer Institute reference terminology for clinical and research data.

INN ID

12959

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Elzocabtagene 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 Elzocabtagene 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

Elzocabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes from peripheral blood obtained by leukapheresis, transduced with four self-inactivating, nonreplicating lentiviral vectors encoding (i) a chimeric antigen receptor (CAR) targeting guanylyl cyclase C (GC-C, GUCY2C), (ii) a chimeric antigen receptor (CAR) targeting CD19 co-expressing interferon gamma (IFN-γ), (iii) a chimeric antigen receptor (CAR) targeting CD19 co-expressing interleukin-6 (IL-6), (iv) a chimeric antigen receptor (CAR) targeting CD19 co-expressing interleukin-12 (IL-12) fused to a von Hippel-Lindau tumour suppressor (VHL) recognition sequence. Each CAR transgene comprises a signal peptide derived from the CD8 alpha chain, a single chain variable fragment (scFv) binding domain, a CD8 hinge and transmembrane domain, a 4-1BB costimulatory domain and a CD3ζ signalling domain, under control of the human elongation factor 1 alpha (EF-1α) core promoter. For the three vectors that also encode a cytokine, each cytokine gene is preceded by an NFAT enhancer and is under the control of a minimal IL-2 promoter. For the IL-12-VHL expressing vector, a recognition sequence of the von Hippel-Lindau tumour suppressor protein (VHL) is fused to the 3' end of the IL-12 gene via an EA rich linker. Each construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (CPPT) and central termination sequence (CTS) and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). Each vector is pseudotyped with the vesicular stomatitis virus (VSV) G envelope protein. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the vector. The cells are then expanded in media with serum replacement and interleukin 2 (IL-2). The T lymphocytes (>75%) are positive for the transgenes (>5% CAR positive), with less than 0.5 % CD19+ cells. The cells produce cytokines (interleukin-6, interleukin-12, and interferon gamma) in co-culture with B lymphocytes

elzocabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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