On April 27, 2020, Professor You Lu’s team published online a research paper titled “Safety and feasibility of CRISPR-edited T cells in patients with refractory non-small-cell lung cancer” in Nature Medicine. This paper reportsresults from a first-in-human phase I clinical trial of CRISPR–Cas9 PD-1-edited T cells in patients with advanced non-small-cell lung cancer (ClinicalTrials.gov NCT02793856). Cells edited with CRISPR prove safe in humans. The first author and corresponding author is Professor You Lu, Department of Thoracic Oncology, West China Hospital. The other co authors are Jianxin Xue and Xiaojuan Zhou. Jianxin Xue is a research fellow and Xiaojuan Zhou is a chief physician of the Department of Thoracic Oncology. SCU’s West China Hospital is the first work unit.

In July 2016, Nature first reported that Professor Lu's team planned to carry out the first human clinical trial of CRISPR – cas9 gene editing. In October 2016, the first patient was treated. “A total of 22 patients were enrolled; 17 had sufficient edited T cells for infusion, and 12 were able to receive treatment. All treatment-related adverse events were grade 1/2. Edited T cells were detectable in peripheral blood after infusion. The median progression-free survival was 7.7 weeks (95% confidence interval, 6.9 to 8.5 weeks) and median overall survival was 42.6 weeks (95% confidence interval, 10.3–74.9 weeks). The median mutation frequency of off-target events was 0.05% (range, 0–0.25%) at 18 candidate sites by next generation sequencing.” (Abstract)

This clinical study is a transformative phase I clinical trial. The publication of its results provides an important basis for the transformation of CRISPR gene editing technology to clinical research.

Professor You Lu isa doctoral supervisor andthe department head of the Department of Thoracic Oncology, West China Hospital. He is also the chief expert of the Health Commission of Sichuan Province andmember of the academic committee of Lung Cancer Quality Control Center of the National Health Commission. His research is mainly focused on the design and implementation of lung cancer targeted therapy, immunotherapy and stereotactic ablation radiotherapy (SABR).In addition, he served as an expert in the compilation of China's Diagnostic and Therapeutic Norms for Primary Lung Cancer, CSCO lung Cancer Guidelines, and NCCN Asian Consensus on Diagnosis and Treatment of Non-Small Cell Lung Cancer. So far, he has published as a corresponding author more than 100 papers in NAT Med, J Clin Oncol, Mole Ther, among other Chinese and international journals; edited three monographs; and translated one monograph.