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 Sat Jun 26 18:50:15 UTC 2021
Edited
by admin
on Sat Jun 26 18:50:15 UTC 2021
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 T-CELLS
Record UNII
Q6C9WHR03O
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
TISAGENLECLEUCEL
USAN   INN  
Official Name English
CTL019
Code English
CAR.CD19-REDIRECTED T CELLS
Common Name English
GENE MODIFICATION OF T CELLS IS MEDIATED BY STABLE INSERTION VIA TRANSDUCTION WITH A SELF-INACTIVATING, REPLICATION-DEFICIENT LENTIVIRAL (LV) VECTOR CONTAINING THE CTL019 TRANSGENE UNDER THE CONTROL OF THE EF-1 ALPHA PROMOTER. THE DRUG PRODUCT IS A MIXTU
Common Name English
TISAGENLECLEUCEL [USAN]
Common Name English
KYMRIAH
Brand Name English
TISAGENLECLEUCEL [INN]
Common Name English
TISAGENLECLEUCEL-T
USAN  
USAN  
Common Name English
CTL-019
Code English
CART-19
Code English
TISAGENLECLEUCEL-T [WHO-DD]
Common Name English
CART19
Code English
Classification Tree Code System Code
EU-Orphan Drug EU/3/14/1266
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
FDA ORPHAN DRUG 415113
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
NCI_THESAURUS C137999
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
FDA ORPHAN DRUG 765120
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
FDA ORPHAN DRUG 422013
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
NCI_THESAURUS C28681
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
FDA ORPHAN DRUG 463114
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
NCI_THESAURUS C129826
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
Code System Code Type Description
FDA UNII
Q6C9WHR03O
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
EVMPD
SUB177825
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
NCI_THESAURUS
C102758
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
CAS
1823078-37-0
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
ChEMBL
CHEMBL3301574
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
RXCUI
1986438
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
INN
10557
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
DRUG BANK
DB13881
Created by admin on Sat Jun 26 18:50:16 UTC 2021 , Edited by admin on Sat Jun 26 18:50:16 UTC 2021
PRIMARY
Related Record Type Details
CHIMERIC PROTEIN ELEMENT->PARENT
TARGET->CYTOTOXIC T-CELL
CHIMERIC PROTEIN ELEMENT->PARENT
Related Record Type Details
ACTIVE MOIETY

Agent Modifications

Modification Process Modification Role Modification Type Amount Fragment Name Fragment ID
CULTURE EXPANSION BIOLOGICAL HUMAN INTERLEUKIN 2, RECOMBINANT NON-GLYCOSYLATED 72WT6YGC0U
TRANSFECTION FOLLOWED BY EXPANSION AND RELEASE FROM MAGNETIC BEADS RECEPTOR EXPRESSION RETROVIRAL TRANSFECTION UNSPECIFIED SUBSTANCE d5204918
T-CELL SELECTION AND ACTIVATION ACTIVATOR IMMUNOLOGICAL UNSPECIFIED SUBSTANCE 4e4ac683

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
VECTOR EXPRESSED PROTEIN TISAGENLECLEUCEL CAR-T RECEPTOR E1A4B5F3ZQ
Name Property Type Amount Referenced Substance Defining Parameters References
Tmax PHARMACOKINETIC TISSUE MEASURED
PHARMACOKINETIC
CD4/CD8 RATIO BIOLOGICAL