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 19:32:20 GMT 2025
Edited
by admin
on Wed Apr 02 19:32:20 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
7VY54Y73ZG
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
Uzatresgene Autoleucel
USAN   INN  
Official Name English
ADP-A2M4CD8
Preferred Name English
autologous CD3+ enriched T lymphocytes obtained from peripheral blood mononuclear cells (PBMCs) by apheresis. The cells are transduced with a self-inactivating, non-replicating lentiviral vector encoding an enhanced-affinity T cell receptor (TCR) targeti
Common Name English
UZATRESGENE AUTOLEUCEL [USAN]
Common Name English
uzatresgene autoleucel [INN]
Common Name English
Code System Code Type Description
NCI_THESAURUS
C162804
Created by admin on Wed Apr 02 19:32:20 GMT 2025 , Edited by admin on Wed Apr 02 19:32:20 GMT 2025
PRIMARY
SMS_ID
300000026212
Created by admin on Wed Apr 02 19:32:20 GMT 2025 , Edited by admin on Wed Apr 02 19:32:20 GMT 2025
PRIMARY
USAN
MN-89
Created by admin on Wed Apr 02 19:32:20 GMT 2025 , Edited by admin on Wed Apr 02 19:32:20 GMT 2025
PRIMARY
FDA UNII
7VY54Y73ZG
Created by admin on Wed Apr 02 19:32:20 GMT 2025 , Edited by admin on Wed Apr 02 19:32:20 GMT 2025
PRIMARY
INN
12870
Created by admin on Wed Apr 02 19:32:20 GMT 2025 , Edited by admin on Wed Apr 02 19:32:20 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 Uzatresgene autoleucel vector encoding MAGE-A4 specific T cell receptor (TCR) plus CD8 alpha co-receptor JT3Q2MC2MT
CULTURE EXPANSION BIOLOGICAL HUMAN INTERLEUKIN-2 FNO32LO217
CULTURE ACTIVATOR BIOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M
CULTURE EXPANSION BIOLOGICAL RAC-ALPHA SERINE/THREONINE-PROTEIN KINASE S0IV3JHN4Z
CULTURE EXPANSION BIOLOGICAL HUMAN AB SERUM S6RLS52G3S

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Uzatresgene autoleucel expressed MAGE-A4 specific T cell receptor (TCR) WDQ7DU232K
VECTOR EXPRESSED PROTEIN Cluster of differentiation 8? 3JY547656H
NUCLEOTIDE INSERTIONS Uzatresgene autoleucel transgene insert encoding MAGE-A4 specific T cell receptor (TCR) plus CD8 alpha co-receptor 3AL52683ZL
VECTOR EXPRESSED PROTEIN Uzatresgene autoleucel expressed MAGE-A4 specific T cell receptor (TCR) plus CD8 alpha co-receptor preprotein H9QR3Y6RKP