SIZAVALEUCEL

Investigational

Approval Year

Substance Class	Structurally Diverse
Source Materials Class	ORGANISM
Source Materials Type	ALLOGENIC HUMAN
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	blood
Fraction Name	cd34+ hscs and cd3+ t-cells
Record UNII	P4NC6C4ABZ
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

MDR-101

Preferred Name

English

SIZAVALEUCEL

Official Name

English

SIZAVALEUCEL [USAN]

Common Name

English

ALLOGENEIC, HLA-MATCHED CD3+ T-CELLS, DERIVED FROM G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS (PBSC) COLLECTED BY APHERESIS. CELLS ARE TRANSPLANT ORGAN DONOR-DERIVED, NON-CULTURED AND CRYOPRESERVED WITH CD34+ HEMATOPOIETIC STEM CELLS (HSC) (FIRZOTEMCEL

Common Name

English

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Code System

Code

Type

Description

SMS_ID

300000039920

PRIMARY

FDA UNII

P4NC6C4ABZ

PRIMARY

USAN

JK-228

PRIMARY

NCI_THESAURUS

C151968

PRIMARY

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Related Record

Type

Details


					P4NC6C4ABZ

SIZAVALEUCEL

ACTIVE MOIETY

Comments:

Maintenance of kidney allograft function

Amount:

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Agent Modifications

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Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
	CD34+ ENRICHMENT			UNSPECIFIED SUBSTANCE	9cd8c8f9

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Name	Property Type	Amount	Referenced Substance	Defining	Parameters	References
ANTIGEN EXPRESSED	BIOLOGICAL	[>4000000] (limits) cells per kg recipient body weigh	`ZWL6BH0E0S` HEMATOPOIETIC PROGENITOR CELL ANTIGEN CD34
ANTIGEN EXPRESSED	BIOLOGICAL	1000000 (average) cells per kg recipient body weight	`ZLW14X2D30` CD3

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