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# Panel to Review First-In-Human Use of CRISPR/Cas9 Gene Editing
- URL: https://www.fdaweb.com/panel-to-review-first-in-human-use-of-crispr-cas9-gene-editing/
- Published: 2016-06-17T12:00:00.000Z
- Updated: 2026-09-14T21:10:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135977

NIH’s Recombinant DNA Advisory committee (RAC) will meet 6/21-22 to review a protocol involving the first-in-human use of gene editing via CRISPR/Cas9 technology. According to a NIH Office of Science Policy [post](http://osp.od.nih.gov/under-the-poliscope/2016/06/emerging-biotechnologies-and-role-nih-rac?ref=fdaweb.com), the T cell immunotherapy protocol involves the use of CRISPR/Cas9 to edit two genes in T cells also modified to express T cell receptors targeting myeloma, melanoma, and sarcoma tumor cells.  
NIH says this exceptional case underlines why the agency recently [announced ](http://osp.od.nih.gov/under-the-poliscope/2016/06/emerging-biotechnologies-and-role-nih-rac?ref=fdaweb.com)revisions to its guidelines that included amending the criteria and process for how human gene transfer protocols would be selected for review by the Recombinant DNA Advisory committee, limiting in depth review and public discussion only for exceptional cases. The agency says that since the week of 6/19-25 marks the 40th anniversary of the first publication of the NIH Guidelines governing experiments using recombinant DNA, it aims to better use the collective breadth of experience of the RAC members in reviewing gene transfer trials and novel technologies that pose unknown risks.