RANICABTAGENE AUTOLEUCEL
UNII V4FF7BKK7M

Substance Identification & Data

This profile provides standardized clinical and technical data for Ranicabtagene Autoleucel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) V4FF7BKK7M.

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

V4FF7BKK7M

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

RANICABTAGENE AUTOLEUCEL

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

NCI Thesaurus

C215284

National Cancer Institute reference terminology for clinical and research data.

INN ID

13546

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Ranicabtagene 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 Ranicabtagene 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

Ranicabtagene Autoleucel

Common Names & Synonyms

autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a nonreplicating gamma-retroviral vector, encoding a chimeric antigen receptor targeting CD19, comprising a CD8α signal peptide, an anti-CD19 single chain variable fragment (scFv) (derived from clone FMC63), a CD8α hinge, a CD28 transmembrane region, an intracellular CD28 co-stimulatory and a CD3ζ signalling domain. The construct is flanked by 5' and 3' long terminal repeats (LTRs), derived from the myeloproliferative sarcoma virus (MPSV) and the murine embryonic stem cell virus (MESV), which contain a 5' LTR promoter and 3' LTR termination sequence. The vector also contains a psi packaging signal and is pseudotyped with gibbon ape leukemia virus (GALV) Env glycoprotein. The leukapheresis material is enriched for CD3+ T lymphocytes by positive immunoselection, prior to activation with CD3 and CD28 agonists. The cells are then transduced with the retroviral vector and expanded in media containing interleukin 2 (IL-2). The T lymphocytes (≥ 90%) are positive for the transgene (≥20% CAR positive), express CD107a (≥20%) and demonstrate cytotoxicity towards CD19 expressing cells

ranicabtagene autoleucel [INN]

External Clinical & Regulatory Resources

Previous UNIIV4FC3H4Y2E

Next UNIIV4FT4F9RC2