TISAGENLECLEUCEL

Approval Year

Substance Class	Structurally Diverse
Source Materials Class	ORGANISM
Source Materials Type	AUTOLOGOUS HUMAN
Source Materials State	LIVE GENETICALLY MODIFIED
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	BLOOD
Fraction Material Type	CELL
Fraction Name	T-CELLS
Record UNII	Q6C9WHR03O
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

TISAGENLECLEUCEL

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

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Classification Tree

Code System

Code

Positive

EU-Orphan Drug

EU/3/14/1266

Designated/Approved

FDA ORPHAN DRUG

463114

Designated/Approved

FDA ORPHAN DRUG

415113

Genetically-engineered Immune Cell

NCI_THESAURUS

C137999

Adoptive Cell Therapy Agent

NCI_THESAURUS

C28681

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Code System

Code

Type

Description

FDA UNII

Q6C9WHR03O

PRIMARY

EVMPD

SUB177825

PRIMARY

USAN

BC-84

PRIMARY

NCI_THESAURUS

C102758

PRIMARY

CAS

1823078-37-0

PRIMARY

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					Q6C9WHR03O

TISAGENLECLEUCEL

ACTIVE MOIETY

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Agent Modifications

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Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
CULTURE	EXPANSION	BIOLOGICAL	9 days (average)	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

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Structural Modifications

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Modification Type	Location Site	Location Type	Residue Modified	Extent	Fragment Name	Fragment Approval
VECTOR EXPRESSED PROTEIN					TISAGENLECLEUCEL CAR-T RECEPTOR	E1A4B5F3ZQ

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Name	Property Type	Amount	Parameters
Tmax	PHARMACOKINETIC	[9 to 10] days (average) maximal expansion of transgene levels.	TISSUE MEASURED PHARMACOKINETIC peripheral blood

CD4/CD8 RATIO	BIOLOGICAL	3.5 (average)