RIBRECABTAGENE AUTOLEUCEL
UNII H9BE3VZU4A

Substance Identification & Data

This profile provides standardized clinical and technical data for Ribrecabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) H9BE3VZU4A.

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

H9BE3VZU4A

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

RIBRECABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C203092

National Cancer Institute reference terminology for clinical and research data.

INN ID

12662

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Ribrecabtagene 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 Ribrecabtagene 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

Ribrecabtagene Autoleucel

Common Names & Synonyms

Autologous T lymphocytes obtained from peripheral blood by leukapheresis, transduced with a self-inactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting the B-cell maturation antigen (BCMA). The expressed transgene comprises a CD8α leader sequence, an anti-BCMA humanized camelid single domain antibody (V HH ), a CD8α hinge and transmembrane domain, and a 4-1BB co-stimulatory domain and CD3ζ signalling domain, under control of the human elongation factor 1 (EF-1) 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 Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE). The vector is pseudotyped with vesicular stomatitis virus (VSV) G glycoprotein (The leukapheresis material is enriched for CD3+ T lymphocytes by positive immunoselection. The lymphocytes are then activated by culture in bags coated with anti-CD3 antibody and recombinant human fibronectin fragment, followed by transduction with the lentiviral vector. The cells are further culture-expanded in growth media containing interleukin 2 (IL-2) and inactivated autologous plasma. The cell suspension consists of T lymphocytes (>95%), with greater than 10% of the T lymphocytes expressing the CAR-BCMA transgene. The transduced T lymphocytes demonstrate cytotoxicity against BCMA-expressing cells (>20%))

ribrecabtagene autoleucel [INN]

External Clinical & Regulatory Resources

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