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 19:21:35 GMT 2025
Edited
by admin
on Wed Apr 02 19:21:35 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
FB64K38TE2
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous peripheral blood mononuclear cells (PBMCs) obtained by leukapheresis enriched for CD3+ T lymphocytes, transduced with a self-inactivating non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19, comprising a
Preferred Name English
Talicabtagene Autoleucel
INN  
Official Name English
talicabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
INN
13539
Created by admin on Wed Apr 02 19:21:35 GMT 2025 , Edited by admin on Wed Apr 02 19:21:35 GMT 2025
PRIMARY
FDA UNII
FB64K38TE2
Created by admin on Wed Apr 02 19:21:35 GMT 2025 , Edited by admin on Wed Apr 02 19:21:35 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
LENTIVIRAL TRANSFECTION TRANSFECTION GENE MODIFICATION Talicabtagene autoleucel lentiviral vector XYJ4596Q2U
CULTURE ACTIVATOR BIOLOGICAL T CELL TRANSACT, HUMAN YG578HEY4V
CULTURE EXPANSION BIOLOGICAL ALDESLEUKIN M89N0Q7EQR

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Talicabtagene autoleucel expressed chimeric antigen receptor (CAR) targeting CD19 GWA9BV7FQD
INSERTED GENE EXPRESSION VECTOR Talicabtagene autoleucel transgene insert W27MEN4E3D