NENDOCABTAGENE ONOGEDLEUCEL
UNII Q137JC2CLV

Substance Identification & Data

This profile provides standardized clinical and technical data for Nendocabtagene Onogedleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) Q137JC2CLV.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2783320-97-6 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

Q137JC2CLV

CAS Registry Number

2783320-97-6

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

NENDOCABTAGENE ONOGEDLEUCEL

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

NCI Thesaurus

C165779

National Cancer Institute reference terminology for clinical and research data.

Substance Type

Nendocabtagene Onogedleucel

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 Nendocabtagene Onogedleucel. 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

Nendocabtagene Onogedleucel

Common Names & Synonyms

ALLO 715 [WHO-DD]

Anti-BCMA CAR T-cell therapy ALLO715

Notes: Allogenic T-cells expressing a chimeric antigen receptor directed to the B-cell maturation antigen (BCMA) for anticipated use in treating patients with multiple myeloma

allogeneic T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis of healthy volunteer donors, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human B-cell maturation antigen (BCMA). The cells are also genetically modified using transcription activator-like (TAL) effector nucleases that are transiently delivered into the cell as mRNAs via electroporation and code for two pairs: one pair is designed for disruption of the T-cell receptor α constant (TRAC) and the other for disruption of the CD52 locus. The expressed transgene comprises a human CD8α leader sequence, an anti-BCMA single chain variable fragment (scFv) derived from the anti-human BCMA (clone P5A2), a CD8α hinge and transmembrane domain, and 4-1BB (CD137) and CD3ζ (CD247) intracellular costimulatory domains, under control of the human elongation factor 1 alpha (EF1α) promoter. The extracellular region of the CAR also contains 2 mimotopes that confer susceptibility to rituximab. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a truncated gag, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and a mutated Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) glycoprotein G. The leukapheresis material is activated by CD3 and CD28 agonists to stimulate T lymphocyte growth in media containing serum and interleukin 2 (IL-2), transduced with the lentiviral vector, genetically modified, and then culture expanded. At the end of expansion, TCR - cells are enriched by positive selection and residual TCR + cells are depleted using magnetic bead purification. The T lymphocytes consist of ≥20% TCR αβ - T lymphocytes expressing the CAR-BCMA transgene, ≥50% CD52 - and ≤3.0% TCR αβ + T lymphocytes. The cells respond to BCMA-expressing target cells by releasing interferon gamma (IFN-γ) and demonstrate cytotoxicity against cells expressing BCMA

nendocabtagene onogedleucel [INN}