Clinical Trial

Disease: Non-small Cell Lung Cancer,NSCLC, (NCT03525782)

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.

In 2021, an estimated 235,760 adults in the United States will be diagnosed with lung cancer. However, since the mid-2000s, incidence rates have dropped by around 2% each year.
Official title:
A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer

Principal Investigator: Size Chen, MD, PhD  First Affiliated Hospital of Guangdong Pharmaceutical University


China, Guangdong

Study start:
Feb. 1, 2018
60 participants
Gene editing method:
Type of edit:
Gene knock out
Programmed Cell Death 1 (PD-1)
Delivery method:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


This is a combined Phase 1 and 2 clinical study. The study goal is to assess the safety and efficacy of anti-MUC1 CAR-T cells and /or PD-1 knockout-engineered T cells for patients with advanced non-small cell lung cancer. All participants will receive at least one cycle of anti-MUC1 CART cell treatment.

  • T cells from the patients will be used to produce anti-MUC1 CAR-T cells and thes cells will be infused back into the patients.

  • PD-1 knockout-engineered T cells will be prepared ex vivo and infused back into the patients.

Last updated: Apr. 8, 2022
Source: US National Institutes of Health (NIH)
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