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The Innovation Drug Discovery > 2026 Vol. 1 > No. 1 > 100013
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Nonclinical research guideline for in vivo generated cell therapy products

  • 1.

    Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

  • 2.

    Beijing Key Laboratory of Oncology Innovative Medicine Regulatory Science, Beijing 100021, China

  • 3.

    National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital of Chinese Academy of Medical Sciences Langfang Campus, Langfang 065001, China

  • 4.

    These authors contributed equally to the work

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The Innovation Drug Discovery  1(1),  https://doi.org/10.59717/j.xinn-drugdisc.2026.100013  |  Cite this article
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    • REFERENCES
  • [1] Food and Drug Administration. (2024). Human Gene Therapy Products Incorporating Human Genome Editing.

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    [2] Bot A., Scharenberg A., Friedman K., et al. (2026). In vivo chimeric antigen receptor (CAR)-T cell therapy. Nat Rev Drug Discov 25:116−137. DOI:10.1038/s41573-025-01291-5

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    [3] ICH Harmonised Guideline (2023). Nonclinical biodistribution considerations for gene therapy products.

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    [4] Chuprin J., Buettner H., Seedhom M. O., et al. (2023). Humanized mouse models for immuno-oncology research. Nat Rev Clin Oncol 20:192−206. DOI:10.1038/s41571-022-00721-2

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    [5] Dunbar C. E., High K. A., Joung J. K., et al. (2018). Gene therapy comes of age. Science 359. DOI:10.1126/science.aan4672.

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  • Cite this article:

    Ding J., Ma P., Zhao G., et al. (2026). Nonclinical research guideline for in vivo generated cell therapy products. The Innovation Drug Discovery 1:100013. https://doi.org/10.59717/j.xinn-drugdisc.2026.100013
    Ding J., Ma P., Zhao G., et al. (2026). Nonclinical research guideline for in vivo generated cell therapy products. The Innovation Drug Discovery 1:100013. https://doi.org/10.59717/j.xinn-drugdisc.2026.100013

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