U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Approval Year

Substance Class Structurally Diverse
Created
by admin
on Wed Apr 02 20:52:49 GMT 2025
Edited
by admin
on Wed Apr 02 20:52:49 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part BLOOD
Fraction Material Type CELL
Fraction Name CD3+ enriched T cells
Record UNII
V4FF7BKK7M
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
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 CD8? signal peptide, an anti-CD19 sing
Preferred Name English
Ranicabtagene Autoleucel
INN  
Official Name English
talicabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
FDA UNII
V4FF7BKK7M
Created by admin on Wed Apr 02 20:52:49 GMT 2025 , Edited by admin on Wed Apr 02 20:52:49 GMT 2025
PRIMARY
INN
13546
Created by admin on Wed Apr 02 20:52:49 GMT 2025 , Edited by admin on Wed Apr 02 20:52:49 GMT 2025
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE EXPANSION BIOLOGICAL ALDESLEUKIN M89N0Q7EQR
CULTURE ACTIVATOR BIOLOGICAL T CELL TRANSACT, HUMAN YG578HEY4V
RETROVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Ranicabtagene autoleucel gamma-retroviral vector SQH56VQ7JL

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Ranicabtagene autoleucel expressed chimeric antigen receptor (CAR) targeting CD19 AJ9UXQ95XU
INSERTED GENE EXPRESSION VECTOR Ranicabtagene autoleucel transgene insert encoding anti-CD19 F9G6M6WX2X