Clinical Trial

Disease: Solid Tumors, (NCT05361174)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours. 

Frequency:
Based on projections, cancer deaths will continue to rise with an estimated 11.4 million cancer-related deaths per year in 2030.
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

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
IndicatorIndicator
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: Jul. 28, 2022
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