Company
Iovance Biotherapeutics
Disease: Solid Tumors, (NCT05361174)
Disease info:
Frequency:
Official title:
A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Who:
Iovance Biotherapeutics Study Team, 866-565-4410, Clinical.Inquiries@iovance.com
Sponsor:
Partners:
Locations:
Not yet disclosed.
Study start:
Jun. 1, 2022
Enrollment:
53
Gene editing method:
TALEN
Type of edit:
Gene knock-out
Gene:
PDCD1
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy
Status: Not yet recruiting
Description
This study is the first-in-human study of IOV-4001, a genetically modified autologous tumour-infiltrating lymphocyte (TIL) product. IOV-4001 is expected to exert anti-tumour activity through its capacity to directly target and kill tumour cells in a manner that is similar to non-genome-edited TILs, but with the potential for enhanced anti-tumour activity through disruption of the PDCD1 gene, which encodes programmed cell death protein-1 (PD-1).
Last updated: Jun. 11, 2022