TACATRESGENE AUTOLEUCEL
UNII AD2HJ5CF2N

Substance Identification & Data

This profile provides standardized clinical and technical data for Tacatresgene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) AD2HJ5CF2N.

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

AD2HJ5CF2N

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

TACATRESGENE AUTOLEUCEL

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

NCI Thesaurus

C203190

National Cancer Institute reference terminology for clinical and research data.

INN ID

11534

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

TACATRESGENE 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 Tacatresgene 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

TACATRESGENE AUTOLEUCEL

Common Names & Synonyms

AUTOLOGOUS T CELLS OBTAINED FROM THE PERIPHERAL BLOOD OF PATIENTS, COLLECTED BY LEUKAPHERESIS, MODIFIED BY CRISPR/CAS9 (CLUSTERED REGULARLY INTERSPACED SHORT PALINDROMIC REPEATS/CRISPR-ASSOCIATED PROTEIN 9) MEDIATED GENE EDITING CONSISTING OF TWO GUIDE RNAS (GRNAS) INTRODUCED TRANSIENTLY AS RIBONUCLEOPROTEIN (RNP) COMPLEX, AND A NEOEPITOPE T CELL RECEPTOR (NEO-TCR) GENE CASSETTE ENCODED BY PLASMID DNA TO REPLACE THE ENDOGENOUS T CELL RECEPTOR (TCR) WITH A SINGLE PATIENT-DERIVED TUMOUR-SPECIFIC NEO-TCR PER T CELL, WITH A MAXIMUM OF THREE DIFFERENT NEO-TCRS IN THE FINAL DRUG SUBSTANCE. THE CONSTANT ELEMENTS OF THE NEO-TCR ARE IDENTICAL FOR EACH PATIENT AND THE NEO-TCR GENE EXPRESSION IS REGULATED BY THE NATIVE ENDOGENOUS TCR PROMOTER. THE T CELLS ARE CULTURED IN THE PRESENCE OF GROWTH MEDIA CONTAINING IL-7 AND IL-15 AND A COMBINATION OF MEMBRANE BOUND ANTI-CD3 AND ANTI-CD28 FOR ACTIVATION. THE T CELLS ARE PREDOMINANTLY CD4 AND CD8 T CELLS (GENERALLY >80%), INCLUDING TMSC (MEMORY STEM CELLS) AND TCM (CENTRAL MEMORY) PHENOTYPES

tacatresgene autoleucel [INN]

External Clinical & Regulatory Resources

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