Non-small cell lung cancer is the most common kind of lung cancer accounting for 80-85% of lung cancers, It is a disease in which malignant (cancer) cells form in the tissues of the lung. People who smoke or who breathe a lot of smoke are most likely to get NSCLC. Many of them are over 65.
Disease: Metastatic Non-small Cell Lung Cancer, NSCLC, (NCT02793856)
Disease info:
Frequency:
Lung cancer is the most common cancer worldwide, accounting for 2.1 million new cases and 1.8 million deaths in 2018.
Official title:
A Phase I Clinical Trial of PD-1 Knockout Engineered T Cells Treating Patients With Advanced Non-small Cell Lung Cancer
Who:
Principal Investigator: You Lu, MD Chair of Department of Thoracic Cancer Sichuan University
Sponsor:
Partners:
Chengdu MedGenCell, Co., Ltd.
Locations:
China, Sichuan
Study start:
Aug. 26, 2016
Enrollment:
12 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene disruption
Gene:
Programmed cell death protein 1 (PD-1)
Delivery method:
Electroporation sgRNA plasmids - Ex-vivo
Safety updates:
Other links:
Lung cancer, American Cancer SocietyAmerican Lung AssociationNews Article: First Chinese CRISPR gene therapy trial demonstrates safetySafety and feasibility of CRISPR-edited T cells in patients with refractory non-small-cell lung cancerCRISPR-Cas9 therapeutics in cancer: promising strategies and present challenges
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy
Status: Completed
Description
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.
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
clinicaltrials.gov
