BELACABNAGENE FRANLEUCEL
UNII JG828PW4NT

Substance Identification & Data

This profile provides standardized clinical and technical data for Belacabnagene Franleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) JG828PW4NT.

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

JG828PW4NT

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

BELACABNAGENE FRANLEUCEL

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

NCI Thesaurus

C206880

National Cancer Institute reference terminology for clinical and research data.

INN ID

12912

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

NO-56

Identifier assigned by the United States Adopted Names Council.

Substance Type

Belacabnagene Franleucel

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 Belacabnagene Franleucel. 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

Belacabnagene Franleucel

Common Names & Synonyms

BELACABNAGENE FRANLEUCEL [USAN]

Human peripheral blood mononuclear cell (PBMC)-derived natural killer (NK) cells transduced with viral vector encoding a CD19-targeting chimeric antigen receptor (CAR) and membrane bound interleukin-15 (mbIL-15)

NKX 019 [WHO-DD]

allogeneic natural killer (NK) cells obtained from peripheral blood mononuclear cells (PBMC) by leukapheresis, transduced with a non-replicating gamma (γ)-retroviral vector encoding a chimeric antigen receptor (CAR) targeting CD19 together with a membrane bound form of human interleukin-15 (mbIL15). The expressed transgene comprises a CD8 alpha (CD8α) leader sequence, a humanized anti-CD19 single-chain variable fragment derived from murine FMC63, a CD8α transmembrane domain, an OX40 costimulatory domain, and a CD3ζ signalling domain, separated by a self-cleaving T2A peptide from IL-15 fused to a CD8α transmembrane domain, which creates a membrane bound form of IL-15 (mbIL-15) under control of a promoter derived from the U3 region of the murine stem cell virus (MSCV) 5' long terminal repeat (LTR). The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a murine embryonic stem cell virus packaging signal. The CD56+ CD3- NK cells are isolated by leukapheresis and cocultured with a modified and irradiated K562 cell line. Specifically, the NK cells are isolated through a series of steps, first to reduce platelets and red blood cells, followed by a CD3+ depletion step, and lastly a positive selection using CD56+ enrichment. The cells are cultured in serum replacement media containing interleukin-12 (IL-12), interleukin-18 (IL-18) and interleukin-2 (IL-2) and co-cultured with a modified and irradiated K562 cell line. The cells are then transduced with the retroviral vector, and the transduced NK cells are further expanded in media containing human AB serum and IL-2

belacabnagene franleucel [INN]

Technical Codes

NKX-019

NKX019

External Clinical & Regulatory Resources

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