Runitresgene Leucel

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 18:37:42 GMT 2025` Edited by `admin` on `Wed Apr 02 18:37:42 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 Name	pmbc
Record UNII	C6LF4ED2YD
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

allogeneic T lymphocytes derived from peripheral blood mononuclear cells (PBMCs) of a haploidentical hematopoietic cell transplantation (HCT) donor that is negative for the HA-2 genotype and/or negative for HLA A*02, engineered by transposon/transposase-

Preferred Name

English

Runitresgene Leucel

Official Name

English

runitresgene leucel [INN]

Common Name

English

Code System Code Type Description

FDA UNII

C6LF4ED2YD

Created by admin on Wed Apr 02 18:37:42 GMT 2025 , Edited by admin on Wed Apr 02 18:37:42 GMT 2025

PRIMARY

INN

13441

Created by admin on Wed Apr 02 18:37:42 GMT 2025 , Edited by admin on Wed Apr 02 18:37:42 GMT 2025

PRIMARY

Related Record Type Details


					5Z6Y4292MB

Minor histocompatibility antigen HA-2

TARGET->CYTOTOXIC T-CELL

Amount:

Related Record Type Details


					C6LF4ED2YD

Runitresgene Leucel

ACTIVE MOIETY

Amount:

Agent Modifications

Modification Process	Modification Role	Modification Type	Fragment Name	Fragment ID
	ACTIVATOR
ELECTROPORATION	GENE EDITING		Pezatresgene leucel mRNA transposase	SBT63KB84C
ELECTROPORATION	GENE EDITING		Runitresgene leucel npDNA Transposon	22TL9L2QGK
	CELLULAR SELECTION
CULTURE	EXPANSION	BIOLOGICAL	HUMAN IL-15	HRJ300HC9W
CULTURE	EXPANSION	BIOLOGICAL	INTERLEUKIN-7 HUMAN RECOMBINANT	418XB47Y71
CULTURE	EXPANSION	BIOLOGICAL	HUMAN INTERLEUKIN-2	FNO32LO217

Structural Modifications

Modification Type	Fragment Name	Fragment Approval
VECTOR EXPRESSED PROTEIN	Pezatresgene leucel expressed transposase	2Q3AFZ2PHR
VECTOR EXPRESSED PROTEIN	Runitresgene leucel expressed T cell receptor targeting HA-2 antigen	6384U7ZZ7R
VECTOR EXPRESSED PROTEIN	Pezatresgene leucel expressed codon-optimized CD8	92NL82868F

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