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 19:49:04 GMT 2025
Edited
by admin
on Wed Apr 02 19:49:04 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
QQ55NF53RR
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous CD4/CD8 enriched T lymphocytes derived from peripheral blood mononuclear cells (PBMC) of patients by leukapheresis, transduced with a selfinactivating, non-replicating lentiviral vector encoding a a chimeric antigen receptor (CAR) targeting th
Preferred Name English
Macitegtagene Autoleucel
INN  
Official Name English
macitegtagene autoleucel [INN]
Common Name English
Code System Code Type Description
NCI_THESAURUS
C211716
Created by admin on Wed Apr 02 19:49:04 GMT 2025 , Edited by admin on Wed Apr 02 19:49:04 GMT 2025
PRIMARY
FDA UNII
QQ55NF53RR
Created by admin on Wed Apr 02 19:49:04 GMT 2025 , Edited by admin on Wed Apr 02 19:49:04 GMT 2025
PRIMARY
INN
13281
Created by admin on Wed Apr 02 19:49:04 GMT 2025 , Edited by admin on Wed Apr 02 19:49:04 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 Macitegtagene autoleucel lentiviral vector ELY7WDV57K
CULTURE EXPANSION BIOLOGICAL INTERLEUKIN-7 HUMAN RECOMBINANT 418XB47Y71
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
VECTOR EXPRESSED PROTEIN Macitegtagene autoleucel expressed human somatostatin receptor type 2 W4VZJ87D9E
INSERTED GENE EXPRESSION VECTOR Macitegtagene autoleucel transgene insert LV296BSH6N
VECTOR EXPRESSED PROTEIN Macitegtagene autoleucel expressed chimeric antigen receptor (CAR) targeting the intercellular adhesion molecule-1 (ICAM-1) C5Z3F98QQV
VECTOR EXPRESSED PROTEIN Macitegtagene autoleucel expressed preprotein (CAR targeting ICAM-1fused to human somatostatin receptor type 2 (SSTR2) separates by P2A peptide) Q6ND6YVF2C