TINOCABTAGENE AUTOLEUCEL
UNII V3JBG9247U

Substance Identification & Data

This profile provides standardized clinical and technical data for Tinocabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) V3JBG9247U.

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

V3JBG9247U

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TINOCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C199018

National Cancer Institute reference terminology for clinical and research data.

INN ID

12483

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Tinocabtagene 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 Tinocabtagene 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

Tinocabtagene Autoleucel

Common Names & Synonyms

Autologous T lymphocytes obtained from peripheral blood lymphocytes by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a bispecific chimeric antigen receptor targeting CD19 and CD22 (Siglec-2). The expressed transgene comprises a CD8α leader sequence, an anti-CD19 and anti-CD22 fully human single chain fragment variable (scFv), 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, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and a mutated Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with 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 optimized serum-free cell culture media with serum replacement and interleukin 2 (IL-2). The T lymphocytes (≥90%; with <5% CD19+/CD22+ B cell impurity) are positive for the transgene (≥10% CAR positive) and secrete interferon gamma (IFN-γ)

tinocabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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