VOLAMCABTAGENE DURZIGEDLEUCEL
UNII S5TX5E9EWP

Substance Identification & Data

This profile provides standardized clinical and technical data for Volamcabtagene Durzigedleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) S5TX5E9EWP.

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
S5TX5E9EWP
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
VOLAMCABTAGENE DURZIGEDLEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
C203062
National Cancer Institute reference terminology for clinical and research data.
INN ID
12102
Sequential identifier assigned via the WHO International Nonproprietary Name program.
Substance Type
VOLAMCABTAGENE DURZIGEDLEUCEL
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 Volamcabtagene Durzigedleucel. 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

VOLAMCABTAGENE DURZIGEDLEUCEL

Common Names & Synonyms

ALLOGENEIC T CELLS OBTAINED FROM PERIPHERAL BLOOD BY LEUKAPHERESIS, GENETICALLY MODIFIED BY CRISPR/CAS9 (CLUSTERED REGULARLY INTERSPACED SHORT PALINDROMIC REPEATS/CRISPR-ASSOCIATED PROTEIN 9) MEDIATED GENE EDITING CONSISTING OF THREE GUIDE RNAS (GRNAS) INTRODUCED TRANSIENTLY AS CAS9-GRNA RIBONUCLEOPROTEIN (RNP) COMPLEX FOR THE TARGETED DISRUPTION OF THE T CELL RECEPTOR ALPHA CHAIN CONSTANT (TRAC), .BETA.2 MICROGLOBULIN (B2M) AND THE CLUSTER OF DIFFERENTIATION 70 (CD70) LOCI AND INSERTION OF AN ANTI-CD70 CHIMERIC ANTIGEN RECEPTOR (CAR) TRANSGENE INTO THE TRAC LOCUS VIA AN ADENO-ASSOCIATED VIRUS SEROTYPE 6 (AAV6) VECTOR. THE CAR IS COMPOSED OF A SIGNAL PEPTIDE SEQUENCE FROM HUMAN CD8A, AN ANTI-CD70 SINGLE-CHAIN VARIABLE FRAGMENT (SCFV) DERIVED FROM ANTI-CD70 HYBRIDOMA 1F6, A CD8 HINGE AND TRANSMEMBRANE DOMAIN, AND THE 4-1BB AND CD3.ZETA. CO-STIMULATORY DOMAINS. EXPRESSION OF THE CAR IS DRIVENBY THE ELONGATION FACTOR 1 ALPHA (EF-1.ALPHA.) PROMOTER AND IS TERMINATED BY A SYNTHETIC POLYADENYLATION (POLYA) SEQUENCE. THE ANTI-CD70 CAR EXPRESSION CASSETTE IS FLANKED BY TWO TRAC HOMOLOGY ARMS GUIDING THE EXPRESSION CASSETTE TO THE TRAC LOCUS AND THE LEUKOPHERESIS MATERIAL IS ENRICHED FOR T CELLS USING CD4/CD8 SELECTION AND ACTIVATED WITH ANTI-CD3/CD28 ANTIBODY-COATED BEADS. T CELLS ARE CULTURED IN THE PRESENCE OF GROWTH MEDIA CONTAINING HUMAN SERUM, INTERLEUKIN 2 (IL-2) AND 7 (IL-7). THE FINAL T CELLS ARE 30% CAR+ T CELLS, 0.4% TCR+, 2% CD70+, AND 30% B2M+ AND SECRETE INTERFERON GAMMA (IFN.GAMMA.) AND IL-2 WHEN CO-CULTURED WITH CD70 EXPRESSING CELL
CTX-130
volamcabtagene durzigedleucel [INN]

Technical Codes

CTX130

External Clinical & Regulatory Resources

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