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 17:49:40 GMT 2025
Edited
by admin
on Wed Apr 02 17:49:40 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
Part blood
Fraction Name CD4+/CD8+ enriched T cells
Record UNII
QTE27WBS5A
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
autologous CD4+/CD8+ enriched T lymphocytes derived from leukapheresis material, transduced with a self-inactivating, non-replicating lentiviral vector encoding a CD19 targeting chimeric antigen receptor (CAR) comprising a CD8 alpha (CD8?) signal peptide
Preferred Name English
Mivocabtagene Autoleucel
INN  
Official Name English
mivocabtagene autoleucel [INN]
Common Name English
Code System Code Type Description
FDA UNII
QTE27WBS5A
Created by admin on Wed Apr 02 17:49:40 GMT 2025 , Edited by admin on Wed Apr 02 17:49:40 GMT 2025
PRIMARY
INN
13488
Created by admin on Wed Apr 02 17:49:40 GMT 2025 , Edited by admin on Wed Apr 02 17:49:40 GMT 2025
PRIMARY
Related Record Type Details
TARGET->CYTOTOXIC T-CELL
IN-VITRO
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE ACTIVATOR BIOLOGICAL HUMAN AB SERUM S6RLS52G3S
CULTURE ACTIVATOR BIOLOGICAL INTERLEUKIN-7 HUMAN RECOMBINANT 418XB47Y71
LENTIVIRAL TRANSFECTION TRANSFECTION BIOLOGICAL Mivocabtagene autoleucel lentiviral vector C3CKE5WGY4
CULTURE EXPANSION BIOLOGICAL INTERLEUKIN-7 HUMAN RECOMBINANT 418XB47Y71

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN Mivocabtagene autoleucel expressed human anti-CD19 CAR VZY7HJ5FSB
INSERTED GENE EXPRESSION VECTOR Mivocabtagene autoleucel transgene insert encoding the anti-CD19 CAR VW2YVK95BV
Name Property Type Amount Referenced Substance Defining Parameters References
ANTIGEN EXPRESSED BIOLOGICAL
ANTIGEN EXPRESSED BIOLOGICAL