ANBALCABTAGENE AUTOLEUCEL
UNII 9JHE6G6VCM

Substance Identification & Data

This profile provides standardized clinical and technical data for Anbalcabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 9JHE6G6VCM.

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

9JHE6G6VCM

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ANBALCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C180584

National Cancer Institute reference terminology for clinical and research data.

INN ID

12186

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Anbalcabtagene 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 Anbalcabtagene 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

Anbalcabtagene Autoleucel

Common Names & Synonyms

Anbalcabtagene autoleucel [WHO-DD]

Autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a chimeric antigen receptor (CAR) targeting CD19, plus two short hairpin RNAs (shRNA) directed against two immune checkpoint regulators, programmed cell death protein 1 (PD-1) and T-cell immunoreceptor with Ig and ITIM domains (TIGIT), the expressed transgene comprises a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) (derived from the mouse hybridoma FMC63), a CD8α hinge and transmembrane region, and a 4-1BB (CD137) and CD3ζ (CD247) intracellular signalling domain, and is under control of the elongation factor 1 alpha (EF1α) promoter. The short hairpin RNA shPD-1 targets the 3' untranslated region part of PD-1 mRNA and is under control of a human U6 promoter. The short hairpin RNA shTIGIT targets a coding sequence part of TIGIT mRNA and is under control of a mouse U6 promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains an HIV-1 ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) and 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 containing serum replacement and interleukin 2 (IL-2). The T lymphocytes (≥97.8%) are positive for the transgene (≥11.0% CAR positive), secrete interferon gamma, and demonstrate knockdown of PD-1 (≥33.7%) or TIGIT (≥83.5%)

anbalcabtagene autoleucel [INN]

External Clinical & Regulatory Resources

Previous UNII9JH486CZ13

Next UNII9JHJ0X6S8V