Developing tests to ensure the safety of gene editing therapies

Validated Immunoassays to Accelerate Therapeutic Genome Editing INDs

NIH-funded research University of California at Davis · NIH-11145386

This study is working on new tests to check how your immune system reacts to gene editing treatments before they are given to people, helping to make sure these therapies are safe and effective.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of California at Davis NIH-funded
Lab location1 site (Davis, United States)
Project IDNIH-11145386 on NIH RePORTER

What this research studies

This research focuses on creating validated immunoassays to monitor the immune response to gene editing therapies before they are tested in humans. By using advanced techniques like cytokine flow cytometry and multiplex immunoassays, the study aims to measure T-cell immunity and antibody responses to gene editing proteins. This will help ensure the safety and effectiveness of these therapies as they move from laboratory studies to clinical trials. The research will also utilize imaging techniques to track immune responses in living organisms.

Who could benefit from this research

Good fit: Ideal candidates for this research are individuals with conditions that may benefit from gene editing therapies, such as genetic disorders or certain cancers.

Not a fit: Patients who do not have conditions that could be treated with gene editing therapies may not receive any benefit from this research.

Why it matters

Potential benefit: If successful, this research could lead to safer gene editing therapies for a variety of diseases.

How similar studies have performed: Previous research has shown promise in using immunoassays for monitoring immune responses in gene therapy, indicating that this approach is both relevant and potentially effective.

Where this research is happening

Davis, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.