Non-viral vectors as beacons of hope for reducing genotoxic risks of gene therapy

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Non-viral vectors as beacons of hope for reducing genotoxic risks of gene therapy
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Nature Biomedical Engineering (2026)Cite this article

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Although promising, gene and cell therapies can pose genotoxic risks that complicate clinical application. We describe the molecular basis of these risks, discuss tools to assess genotoxicity and highlight the advantages of non-viral genome engineering technologies for safer genome engineering.

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Acknowledgements

Work in the authors’ laboratory has been supported by the Innovative Medicines Initiative 2 Joint Undertaking (T2Evolve, grant 945393), by Stiftung Deutsche Krebshilfe (German Cancer Aid) as part of the preclinical cancer drug development network (preCDD) and the CAR Factory consortium (grant 70115200), by the Deutsche Forschungsgemeinschaft (German Research Foundation, grant IV 21/22-1), by the NC3Rs’ CRACK IT Challenge programme under grant NC/C022201/01 and by the German Cancer Consortium (DKTK) at the German Cancer Research Center (DKFZ), Heidelberg, Germany.

Author information

Authors and Affiliations

  1. Institute of Clinical Immunology, University of Leipzig, Leipzig, Germany

    Marie-Madeleine Nzila, Ulrike Koehl & Zoltán Ivics

  2. Fraunhofer Institute for Cell Therapy and Immunology, Leipzig, Germany

    Ulrike Koehl & Zoltán Ivics

  3. German Cancer Consortium (DKTK), partner site Heidelberg, Heidelberg, Germany

    Zoltán Ivics

Authors

  1. Marie-Madeleine Nzila
  2. Ulrike Koehl
  3. Zoltán Ivics

Contributions

M.-M.N. prepared the figures and wrote the first draft of the manuscript. U.K. contributed to the writing of the manuscript. Z.I. extended and finalized the manuscript.

Corresponding author

Correspondence to Zoltán Ivics.

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Competing interests

Z.I. is co-inventor of several patents relating to Sleeping Beauty transposon technology and is a member of the scientific advisory board of NanoCell Therapeutics. M.-M.N. and U.K. declare no competing interests.

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Cite this article

Nzila, MM., Koehl, U. & Ivics, Z. Non-viral vectors as beacons of hope for reducing genotoxic risks of gene therapy. Nat. Biomed. Eng (2026). https://doi.org/10.1038/s41551-025-01581-8

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  • DOI: https://doi.org/10.1038/s41551-025-01581-8