INATICABTAGENE AUTOLEUCEL
UNII W8VE86L4EU

Substance Identification & Data

This profile provides standardized clinical and technical data for Inaticabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) W8VE86L4EU.

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
W8VE86L4EU
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
INATICABTAGENE AUTOLEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
C199061
National Cancer Institute reference terminology for clinical and research data.
INN ID
12418
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
Inaticabtagene 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 Inaticabtagene 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

Inaticabtagene Autoleucel

Common Names & Synonyms

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 targeting CD19. The expressed transgene comprises a CD8α leader sequence, an anti-CD19 single chain variable fragment (scFv) derived from clone HI19a, a CD8α hinge and transmembrane region, and a 4-1BB and CD3ζ signalling domain and is under control of the elongation factor 1 alpha (EF1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, parts of the gag and env genes, a Rev response element (RRE), a central polypurine tract (cPPT) sequence, a Kozak sequence, and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 magnetic beads and transduced with the vector. The cells are then expanded in media supplemented with serum replacement and interleukin 2 (IL-2). The T lymphocytes (≥90%) are positive for the transgene (≥15% CAR positive), secrete interferon gamma, and demonstrate cytotoxicity against CD19 expressing cells
Inaticabtagene autoleucel [INN]
Inaticabtagene autoleucel [WHO-DD]

External Clinical & Regulatory Resources

NCATS
Inxight Drugs
NLM
DailyMed Products
NCATS
GSRS Full Record
NIH
NCI Thesaurus