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 include sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours. 

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


Iovance Biotherapeutics Study Team

Phone: 866-565-4410



United States, California

The Angeles Clinic and Research Institute: Recruiting

Los Angeles, California, United States, 90025

United States, Florida

Orlando Health Cancer Institute: Recruiting

Orlando, Florida, United States, 32610

United States, Kansas

The University of Kansas Cancer Center: Recruiting

Westwood, Kansas, United States, 66205

United States, Kentucky

University of Louisville: Recruiting

Louisville, Kentucky, United States, 40202

United States, New York

Memorial Sloan Kettering Cancer Center: Recruiting

New York, United States, 10065

United States, Ohio

University of Cincinnati: Recruiting

Cincinnati, Ohio, United States, 45219

United States, Wisconsin

Medical College of Wisconsin: Recruiting

Milwaukee, Wisconsin, United States, 53226


Contact: Iovance Biotherapeutics Study Team866-565-4410

Study start:
Jun. 1, 2022
Gene editing method:
Type of edit:
Gene knock-out
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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. 5, 2023
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