ACMUCABTAGENE AUTOLEUCEL
UNII 33KHD8ZZ8Y

Substance Identification & Data

This profile provides standardized clinical and technical data for Acmucabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 33KHD8ZZ8Y.

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

33KHD8ZZ8Y

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ACMUCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C203090

National Cancer Institute reference terminology for clinical and research data.

INN ID

11832

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

ACMUCABTAGENE 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 Acmucabtagene 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

ACMUCABTAGENE AUTOLEUCEL

Common Names & Synonyms

AUTOLOGOUS T CELLS OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS BY LEUKAPHERESIS, TRANSDUCED WITH A SELFINACTIVATING, NON-REPLICATING LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING B-LYMPHOCYTE ANTIGEN CD19 (ALSO KNOWN AS B-LYMPHOCYTE SURFACE ANTIGEN B4) UNDER CONTROL OF THE MURINE STEM CELL VIRUS PROMOTER. THE TRANSGENE IS A T CELL ANTIGEN COUPLER (TAC)WHICH HAS THREE COMPONENTS:(I) AN EXTRACELLULAR ANTIGEN-BINDING DOMAIN (ANTI-HUMAN CD19 FMC63 SINGLE CHAIN VARIABLE FRAGMENT (SCFV)), (II) AN EXTRACELLULAR T CELL RECEPTOR (TCR) RECRUITMENT DOMAIN (ANTIHUMAN CD3.EPSILON.UCHT1 SCFV (Y177T)), AND (III) A MEMBRANEANCHORING CO-RECEPTOR DOMAIN THAT CONSISTS OF THE TRANSMEMBRANE AND CYTOPLASMIC DOMAINS OF CD4. THE VECTOR GENOME IS FLANKED BY 5' AND 3' LONG TERMINAL REPEATS (LTRS) AND CONTAINS ALSO A .PSI. PACKAGING SIGNAL, A REV RESPONSE ELEMENT (RRE), A CENTRAL POLYPURINE TRACT (CPPT) SEQUENCE AND THE WOODCHUCK HEPATITIS VIRUS POST-TRANSCRIPTIONAL REGULATORY ELEMENT (WPRE). THE LEUKAPHERESIS MATERIAL IS ENRICHED FOR CD4/CD8 T CELLS BY POSITIVE MMUNOSELECTION. T CELLS ARE CULTURED IN THE PRESENCE SERUM-FREE MEDIUM CONTAINING IL-2 AND IL-7, AND ACTIVATED USING A CD3/CD28/CD2 SOLUBLE ACTIVATOR. THE T CELLS (>70%,GENERALLY 99%) ARE PREDOMINANTLY CD4 AND CD8 T CELLS, WITH >10% VIABLE CD3+TAC+ CELLS

acmucabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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