Pezatresgene Leucel

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 18:49:46 GMT 2025` Edited by `admin` on `Wed Apr 02 18:49:46 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	ALLOGENIC HUMAN
Source Materials State	LIVE GENETICALLY MODIFIED
Source Materials Parent	`G0T704E6Z3` HOMO SAPIENS WHOLE
Part	blood
Fraction Material Type	cell
Fraction Name	pmbc
Record UNII	E4Y8KU8Q77
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

Pezatresgene Leucel

Official Name

English

allogeneic T lymphocytes derived from peripheral blood mononuclear cells (PBMCs) of a haploidentical hematopoietic cell transplantation (HCT) donor that is negative for the HA-1 genotype and/or negative for HLA A*02, engineered by transposon/transposase-

Preferred Name

English

pezatresgene leucel [INN]

Common Name

English

Code System Code Type Description

INN

13440

Created by admin on Wed Apr 02 18:49:46 GMT 2025 , Edited by admin on Wed Apr 02 18:49:46 GMT 2025

PRIMARY

FDA UNII

E4Y8KU8Q77

Created by admin on Wed Apr 02 18:49:46 GMT 2025 , Edited by admin on Wed Apr 02 18:49:46 GMT 2025

PRIMARY

Related Record Type Details


					E4BZA4K3WP

Minor histocompatibility antigen HA-1

TARGET->CYTOTOXIC T-CELL

Amount:

Related Record Type Details


					E4Y8KU8Q77

Pezatresgene Leucel

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Amount	Fragment Name	Fragment ID
ELECTROPORATION	GENE EDITING			Pezatresgene leucel npDNA Transposon	P785NES5QX
ELECTROPORATION	GENE EDITING			Pezatresgene leucel mRNA transposase	SBT63KB84C

Structural Modifications

Modification Type	Fragment Name	Fragment Approval
VECTOR EXPRESSED PROTEIN	Pezatresgene leucel expressed codon-optimized CD8	92NL82868F
VECTOR EXPRESSED PROTEIN	Pezatresgene leucel expressed exogenous T cell receptor targeting HA-1 antigen	LP449BE55Q
VECTOR EXPRESSED PROTEIN	Pezatresgene leucel expressed transposase	2Q3AFZ2PHR

Name	Property Type	Amount	Referenced Substance	Defining	Parameters	References
ANTIGEN EXPRESSED	BIOLOGICAL		`2946IE3VYD` CD8
ANTIGEN EXPRESSED	BIOLOGICAL		`8OYI5QX0HL` T-CELL SURFACE GLYCOPROTEIN CD4