RAPCABTAGENE AUTOLEUCEL
UNII EJG3KK52YP

Substance Identification & Data

This profile provides standardized clinical and technical data for Rapcabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) EJG3KK52YP.

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

EJG3KK52YP

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

RAPCABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C175534

National Cancer Institute reference terminology for clinical and research data.

INN ID

11974

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

LM-110

Identifier assigned by the United States Adopted Names Council.

Substance Type

Rapcabtagene 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 Rapcabtagene 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

Rapcabtagene Autoleucel

Common Names & Synonyms

ANTI-CD19 CAR-T CELL THERAPY YTB323

Autologous T cells obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a self-inactivating, nonreplicating lentiviral vector, encoding a T cell chimeric antigen receptor targeting CD19. The expressed transgene comprises a CD8α leader sequence, a murine anti-CD19 single chain variable fragment (scFv) derived from the mouse hybridoma FMC63, a CD8α hinge and transmembrane region, and a 4-1BB (CD137) and CD3ζ (TCRζ) signaling domain and is under control of the elongation factor 1 alpha (EF1α) 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 an optimized Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The leukapheresis material is enriched for CD4/CD8 T cells by positive immunoselection, activated by CD3 and CD28 agonists and transduced with the vector. Without further cell propagation, the T cells are washed, formulated for infusion, and cryopreserved. The substance is composed of ≥80% T cells and ≤1% B cells, with a mixture of transgene positive (>3.4%) and negative T cells. The CD4+ and CD8+ naïve T cell subsets (CD45RA+CCR7+) present in the leukapheresis material are largely retained

RAPCABTAGENE AUTOLEUCEL [USAN]

rapcabtagene autoleucel [INN]

Technical Codes

YTB-323

YTB323

External Clinical & Regulatory Resources

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