ZIPIDCABGENE AUTOLEUCEL
UNII LV9G9H8D3J

Substance Identification & Data

This profile provides standardized clinical and technical data for Zipidcabgene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) LV9G9H8D3J.

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

LV9G9H8D3J

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ZIPIDCABGENE AUTOLEUCEL

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

INN ID

13734

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Zipidcabgene 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 Zipidcabgene 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

Zipidcabgene Autoleucel

Common Names & Synonyms

autologous peripheral blood mononuclear cell (PBMC)-derived T lymphocytes obtained by leukapheresis, transduced with a self-inactivating non-replicating lentiviral vector encoding a looped bispecific chimeric antigen receptor (CAR) targeting both CD19 and B cell maturation antigen (BCMA), comprising a CD8 leader sequence, an anti-CD19 single-chain variable fragment (scFv) (derived from clone FMC63) plus an anti-BCMA scFv, linked to one CD8 hinge and transmembrane region, followed by a 4-1BB co-stimulatory domain and a CD3ζ intracellular signal transduction domain, under control of an elongation factor 1 alpha (EF-1α) promoter and the Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE). The vector genome also contains an HIV-1 packaging signal (ψ), a Rev response element (RRE), a central polypurine tract (cPPT)/central termination sequence (CTS) and is flanked by 5' and 3' long terminal repeats (LTRs). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein. The leukapheresis material is enriched for T lymphocytes by positive immunoselection prior to activation with CD3 and CD28 agonists in growth media containing interleukin 2 (IL-2). The cells are then transduced with the lentiviral vector and expanded in growth media containing IL-2 and human serum albumin. The cell suspension consists of T lymphocytes (≥70%), with ≥5% of the T lymphocytes expressing the CD19/BCMA CAR transgene.

zipidcabgene autoleucel [INN]

External Clinical & Regulatory Resources

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