Clinical Trial

Disease: Non-small Cell Lung Cancer, NSCLC, (NCT02793856)

Disease info:

Lung cancer 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.

Lung cancer is the second most common cancer in the United States. The American Cancer Society estimates approximately 238,340 new cases of lung cancer will be diagnosed in 2023.
Official title:
A Phase I Clinical Trial of PD-1 Knockout Engineered T Cells Treating Patients With Advanced Non-small Cell Lung Cancer

Principal Investigator: You Lu, MD Chair of Department of Thoracic Cancer Sichuan University


Chengdu MedGenCell, Co., Ltd.


China, Sichuan

West China Hospital, Sichuan University, Chengdu, Sichuan, China, 610041


Study start:
Aug. 26, 2016
12 participants
Gene editing method:
Type of edit:
Gene knock-out
Programmed cell death protein 1 (PDCD1 or PD-1)
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed


This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR-Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients.

Last updated: Apr. 20, 2024
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