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. 

Lung cancer is a type of solid tumour forming cancer that is generally divided into two types: small cell lung cancer and non-small cell lung cancer, based on the size of the affected cells when viewed under a microscope. Non-small cell lung cancer accounts for 85 % of lung cancer, while small cell lung cancer accounts for the remaining 15 %.

Lung cancer may not cause signs or symptoms in its early stages. Some people with lung cancer have chest pain, frequent coughing, blood in the mucus, breathing problems, trouble swallowing or speaking, loss of appetite and weight loss, fatigue, or swelling in the face or neck. Additional symptoms can develop if the cancer spreads (metastasises) into other tissues.

Non-small cell lung cancer is divided into three main subtypes: adenocarcinoma, squamous cell carcinoma, and large cell lung carcinoma. Adenocarcinoma arises from the cells that line the small air sacs located throughout the lungs. Squamous cell carcinoma arises from squamous cells that line the passages leading from the windpipe to the lungs (bronchi). Large cell carcinoma arises from epithelial cells that line the lungs. Large cell carcinoma encompasses non-small cell lung cancers that do not appear to be adenocarcinomas or squamous cell carcinomas. The 5-year survival rate for people with non-small cell lung cancer is usually between 11 and 17 %, but this can be lower or higher depending on the subtype and stage of the cancer.


More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023..
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: Dec. 19, 2023
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