PRIZLONCABTAGENE AUTOLEUCEL
UNII 35X9XB2HBG

Substance Identification & Data

This profile provides standardized clinical and technical data for Prizloncabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 35X9XB2HBG.

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

35X9XB2HBG

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

PRIZLONCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C178452

National Cancer Institute reference terminology for clinical and research data.

INN ID

12614

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Prizloncabtagene 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 Prizloncabtagene 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

Prizloncabtagene Autoleucel

Common Names & Synonyms

Prizloncabtagene autoleucel [WHO-DD]

autologous T lymphocytes obtained from peripheral blood lymphocytes by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector, encoding a bispecific chimeric antigen receptor targeting CD19 and CD20. The expressed transgene comprises a CD8α leader sequence, anti-CD19 and anti-CD20 single chain fragment variable (scFv) (derived from FMC-63 and ofatumumab, respectively), an IgG4 hinge and a CD28 transmembrane region, a 4-1BB and a CD3ζ signalling domain, and is under control of the elongation factor 1 alpha (EF1α) short promoter. The construct is flanked by 5' and 3' long terminal repeats (LTRs) and also contains a ψ packaging signal, a Rev response element (RRE), a central polypurine tract (cPPT) sequence and a mutated Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) G envelope protein. The leukapheresis material is enriched for CD4/CD8 T lymphocytes by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the lentiviral vector. The cells are then expanded in media with serum replacement and interleukin 2 (IL-2). The T lymphocytes (≥95%) are positive for the transgene (≥10% CAR positive), and secrete interferon gamma in response to CD19 and CD20 expressing tumour cell lines

prizloncabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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