AZERCABTAGENE ZAPRELEUCEL
UNII PFZ3AP93TA

Substance Identification & Data

This profile provides standardized clinical and technical data for Azercabtagene Zapreleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) PFZ3AP93TA.

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
PFZ3AP93TA
CAS Registry Number
N/A
RxNorm Concept ID
N/A

Detailed Substance Profile

Preferred Name
AZERCABTAGENE ZAPRELEUCEL
Official standardized name for this substance within the FDA UNII nomenclature system.
NCI Thesaurus
C158558
National Cancer Institute reference terminology for clinical and research data.
INN ID
11438
Sequential identifier assigned via the WHO International Nonproprietary Name program.
USAN ID
MN-134
Identifier assigned by the United States Adopted Names Council.
Substance Type
AZERCABTAGENE ZAPRELEUCEL
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 Azercabtagene Zapreleucel. 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

AZERCABTAGENE ZAPRELEUCEL

Common Names & Synonyms

AZERCABTAGENE ZAPRELEUCEL [USAN]
Adult allogeneic CD4+ and CD8+ enriched T cells transduced with an anti-CD19 chimeric antigen receptor (CAR) that is site-specific integrated into the cellular genome. Adult allogeneic CD4+ and CD8+ enriched T cells, gene edited through the electroporation of homing endonuclease mRNA, which is translated into endonuclease protein that introduces a double stranded DNA break in exon 1 of the endogenous T cell receptor alpha constant (TRAC) locus. Cells are subsequently transduced with a recombinant nonreplicating adeno-associated virus type 6 (rAAV6) vector, encoding an anti-CD19 CAR transgene consisting of a murine CD19-specific scFv (clone FMC63), a CD8 hinge/transmembrane domain, a novel 6 (N6) co-stimulatory domain and CD3 zeta signaling domain, under the control of the synthetic promoter JeT and the SV40 poly(A) signal. CAR transgene integration is achieved via homology directed recombination at the endonuclease target site (exon 1 of TRAC). Depletion of CD3+ cells is performed on the transduced cells to remove cells with functional endogenous T cell receptor (TCR). The substance is a mixture of non-effector (naive, stem cell memory, central memory) (CCR7+) and effector memory and effector (CCR7-) CD4+ and CD8+ T cells with generally ≥99% T cell receptor knockout, and ≥40% anti-CD19 CAR knock-in. Activation of the cells is accompanied in vitro by release of IFNγ, IL-2, IL-6, and TNFα in an antigen-dependent manner
Allogeneic anti-human-CD19 CAR T cell product derived from healthy donor T cells that are genetically edited to (a) remove the expression of the endogenous T cell receptor (TCR) and (b) insert an anti-CD19 CAR gene, thereby providing the ability to specifically target, bind to, and kill CD19+ cells.
Azercabtagene zapreleucel [WHO-DD]
azercabtagene zapreleucel [INN]

Technical Codes

PBCAR-0191
PBCAR0191

External Clinical & Regulatory Resources

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