China poised to make CRISPR history with first in vivo trial

China

A research team led by You Lu has received ethics clearance for what is expected to be the first in vivo trial using CRISPR gene editing technology. The Phase I trial is slated to be conducted at the West China Hospital.

The Sichuan University research team will employ CRISPR-Cas-9, a new editing technique that will target advanced non-small cell lung cancer in a trial aimed at safety, with secondary endpoints of progression-free survival, overall survival and response rate, according to a notice on Clinicaltrials.gov and an article in Nature.

The trial could begin by September, according to the journal.

Chinese researchers received an official nod to move aggressively into gene-sequencing in June of last year as Vice-Minister of Science and Technology Cao Jianlin said that efforts to harness the technology should proceed.

"Now China has taken the lead in DNA sequencing, a technology that enables DNA sequencing on infants to discover possible genetic diseases early," Cao said in a State Council briefing press conference in June 2015.

"Every time such technologies appear and bring about some new industries, there tends to be conflict and confrontation with the existing standards and industries. Generally speaking, we take an active attitude toward such progress because we know that no one can resist it and what we should do is make adjustments accordingly."

The U.S. National Institutes of Health has also approved a CRISPR-related in vivo clinical effort, but the U.S. FDA and an ethics review board have yet to sign off, though work could come by the end of the year.

Both efforts target T cells, but the China trial aims to disable the protein PD-1 that allows tumors to avoid an immune response.

“I hope we are the first," Lu told Nature. "And more importantly, I hope we can get positive data from the trial.”

- here's the article in Nature
- and the link to Clinicaltrials.gov

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