DURCABTAGENE AUTOLEUCEL
UNII D6ZL787LZ9

Substance Identification & Data

This profile provides standardized clinical and technical data for Durcabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) D6ZL787LZ9.

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

D6ZL787LZ9

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DURCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C199006

National Cancer Institute reference terminology for clinical and research data.

INN ID

12461

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Durcabtagene 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 Durcabtagene 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

Durcabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting human B cell maturation antigen (BCMA). The expressed transgene comprises a CD8α leader sequence, an anti-BCMA single chain variable fragment (scFv), a CD8α hinge and transmembrane domain, and a 4-1BB (CD137) and CD3ζ signalling domain, under control of the human elongation factor 1α (EF-1α) promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a truncated gag, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and a synthetic ID tag sequence. The leukapheresis material is enriched for CD4+ and CD8+ T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector in serum-free media containing interleukin 2 (IL-2). Without further cell propagation in vitro, the T lymphocytes are washed, formulated for infusion, and cryopreserved. The T lymphocytes phenotype very closely resembles that of the initial leukapheresis material. The cell suspension consists of T lymphocytes (≥80%; ≤1% B cells), with a minimum of 4.0% of the T lymphocytes expressing the CAR-BCMA transgene. The T lymphocytes secrete interferon gamma (IFN-γ) and IL-2 following co-culture with BCMA-expressing cells

durcabtagene autoleucel [INN]

External Clinical & Regulatory Resources

Previous UNIID6ZH4E9SP7

Next UNIID6ZP6F2ECK