U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
This repository is under review for potential modification in compliance with Administration directives.

Approval Year

2017
411
Substance Class Structurally Diverse
Created
by admin
on Mon Mar 31 22:19:34 GMT 2025
Edited
by admin
on Mon Mar 31 22:19:34 GMT 2025
Source Materials Class ORGANISM
Source Materials Type AUTOLOGOUS HUMAN
Source Materials State LIVE GENETICALLY MODIFIED
Source Materials Parent
HOMO SAPIENS WHOLE
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
TISAGENLECLEUCEL-T
USAN  
USAN  
Preferred 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 [WHO-DD]
Common Name English
tisagenlecleucel [INN]
Common Name English
CTL-019
Code English
CART-19
Code English
CART19
Code English
Classification Tree Code System Code
EU-Orphan Drug EU/3/14/1266
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
FDA ORPHAN DRUG 463114
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
FDA ORPHAN DRUG 415113
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
NCI_THESAURUS C137999
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
NCI_THESAURUS C28681
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
NCI_THESAURUS C129826
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
FDA ORPHAN DRUG 422013
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
FDA ORPHAN DRUG 765120
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
Code System Code Type Description
FDA UNII
Q6C9WHR03O
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
EVMPD
SUB177825
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
USAN
BC-84
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
NCI_THESAURUS
C102758
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
CAS
1823078-37-0
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
ChEMBL
CHEMBL3301574
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
DAILYMED
Q6C9WHR03O
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
RXCUI
1986438
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
INN
10557
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
WIKIPEDIA
Tisagenlecleucel
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
SMS_ID
100000163519
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
DRUG BANK
DB13881
Created by admin on Mon Mar 31 22:19:34 GMT 2025 , Edited by admin on Mon Mar 31 22:19:34 GMT 2025
PRIMARY
Related Record Type Details
4-1BB COSTIMULATORY DOMAIN
CHIMERIC PROTEIN ELEMENT->PARENT
CD19 POSITIVE CELLS
TARGET->CYTOTOXIC T-CELL
CD3 ZETA CHAIN SIGNALLING DOMAIN
CHIMERIC PROTEIN ELEMENT->PARENT
Related Record Type Details
TISAGENLECLEUCEL
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 Rapcabtagene autoleucel vector R13Q0H748L
T-CELL SELECTION AND ACTIVATION ACTIVATOR IMMUNOLOGICAL ANTI-CD3/ANTI-CD28 4.5 MICRON MAGNETIC BEADS PA28ZKP50M

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
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
For language access assistance, contact the NCATS Public Information Officer
National Center for Advancing Translational Sciences (NCATS),
6701 Democracy Boulevard, Bethesda MD 20892-4874 • 301-594-8966