TALICABTAGENE AUTOLEUCEL
UNII FB64K38TE2

Substance Identification & Data

This profile provides standardized clinical and technical data for Talicabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) FB64K38TE2.

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

FB64K38TE2

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TALICABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C215774

National Cancer Institute reference terminology for clinical and research data.

INN ID

13539

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Talicabtagene 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 Talicabtagene 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

Talicabtagene Autoleucel

Common Names & Synonyms

autologous peripheral blood mononuclear cells (PBMCs) obtained by leukapheresis enriched for CD3+ T lymphocytes, transduced with a self-inactivating non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19, comprising a CD8α leader sequence, a humanised anti-CD19 single chain variable fragment (scFv; derived from the FMC63 antibody), human CD8α hinge and transmembrane domain, human 4-1BB co-stimulatory domain and human CD3ζ signalling domain, under control of the elongation factor-1 alpha (EF-1α) promoter. The vector genome also contains an HIV-1 packaging signal (ψ), a Rev response element (RRE), a central polypurine tract (cPPT)/central termination sequence (CTS) and is flanked by 5' and 3' long terminal repeats (LTRs). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for CD3+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media supplemented with human AB serum and interleukin 2 (IL-2). The T lymphocytes (≥95%) are positive for the transgene (≥15% CAR positive) and are cytotoxic (≥50%) when co-cultured with CD19 expressing tumour cell lines

talicabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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