Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required)
Limited competition grant available for U19 awardees to expand research scopes for human genome editing clinical trials, building on prior funding restrictions.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: May 29, 2025 | September 26, 2025 | February 13, 2026 | May 29, 2026
Funding Amounts: No set budget limit; up to 3 years; up to 2 awards; additional $2.6M may be available per awardee.
Summary: Limited competition for U19 awardees to expand to first-in-human somatic cell genome editing clinical trials using candidates developed under prior NIH funding.
Key Information: Only current U19 awardees from RFA-RM-22-015 are eligible; clinical trial and pre-IND meeting required.
Description
This opportunity supports competitive revision applications from current U19 awardees funded under RFA-RM-22-015 (NIH Somatic Cell Genome Editing program) to expand their research scope and conduct first-in-human clinical trials using genome editing therapeutic candidates developed under their original award. The original U19 mechanism did not permit clinical trials; this revision is specifically for projects ready to transition to early-stage human studies.
The program is part of the NIH Common Fund's Somatic Cell Genome Editing (SCGE) initiative, aiming to accelerate the translation of genome editing technologies into clinical applications for genetic diseases. The focus is on supporting "Trailblazer" projects that have completed IND-enabling studies and are poised for first-in-human trials.
