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 19:49:34 GMT 2025
Edited
by admin
on Wed Apr 02 19:49:34 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE
Source Materials Parent
Part blood
Fraction Name cd4/cd8 enriched t cells
Record UNII
LN7HYS3NX9
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous T lymphocytes obtained from peripheral blood mononuclear cells by leukapheresis, transduced with a selfinactivating, non-replicating lentiviral vector encoding a chimeric antigen receptor (CAR) targeting CD19. The expressed transgene comprises
Preferred Name English
Nespecabtagene Autoleucel
Common Name English
nespecabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
NCI_THESAURUS
C211707
Created by admin on Wed Apr 02 19:49:34 GMT 2025 , Edited by admin on Wed Apr 02 19:49:34 GMT 2025
PRIMARY
INN
13126
Created by admin on Wed Apr 02 19:49:34 GMT 2025 , Edited by admin on Wed Apr 02 19:49:34 GMT 2025
PRIMARY
FDA UNII
LN7HYS3NX9
Created by admin on Wed Apr 02 19:49:34 GMT 2025 , Edited by admin on Wed Apr 02 19:49:34 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 Nespecabtagene autoleucel lentiviral vector Q4SEW48YGM
CULTURE ACTIVATOR T CELL TRANSACT, HUMAN YG578HEY4V
CULTURE EXPANSION BIOLOGICAL HUMAN INTERLEUKIN-2 FNO32LO217

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
INSERTED GENE EXPRESSION VECTOR UNSPECIFIED SUBSTANCE
28aee4c4
(not in database)
VECTOR EXPRESSED PROTEIN Nespecabtagene autoleucel expressed chimeric antigen receptor (CAR) targeting CD19 L6JVC846XW