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Background <p>Acute myeloid leukemia (AML) remains a significant challenge in hematologic oncology, with high relapse rates and limited treatment options. Natural killer (NK) cells, as key effectors of innate immunity, have shown strong anti-leukemic activity, making them promising candidates for immunotherapy. Despite increasing clinical interest, a comprehensive evaluation of NK cell-based therapies in AML is still needed.</p> Methods <p>This systematic review follows the PRISMA guidelines to analyze clinical trials evaluating NK cell therapy in AML, either as a standalone treatment or in combination with hematopoietic stem cell transplantation (HSCT). A literature search across five major databases identified relevant studies, with data extraction focusing on NK cell sources, isolation and expansion strategies, clinical efficacy, and safety outcomes.</p> Results <p>A total of 48 clinical trials were identified, including 27 trials specific to AML and 21 trials involving AML along with other hematologic malignancies. Peripheral blood (PB)-derived NK cells were the main source (82%), with purification methods mainly using CliniMACS-based CD3 depletion and CD56 selection. Short-term activation (≤ 24&#xa0;h) and long-term expansion (&gt; 7 days) were employed in 36% of studies each. In non-HSCT transplant settings, NK cell therapy achieved a complete remission (CR) rate of 37.1% and an event-free survival (EFS) of 71.3%, while post-HSCT overall survival (OS) reached 39.5%. Notably, graft-versus-host disease (GVHD) incidence stayed low, highlighting the favorable safety profile of NK cell therapy.</p> Conclusion <p>NK cell-based therapy represents a promising and well-tolerated immunotherapeutic approach for AML. However, optimizing NK cell expansion, persistence, and clinical applications requires further investigation through large-scale, controlled trials.</p>

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A systematic review of the last two decades of NK cell-based clinical trials: state of the art of AML therapy

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月30日

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  • Mehdi Bakhtiyaridovvombaygi,
  • Setare Kheyrandish,
  • Seyed Mehrab Safdari,
  • Shiva Eskandrian,
  • Hassan Rousta,
  • Dawood Hossaini,
  • Amirhossein Rastgar,
  • Somayeh Yazdanparast,
  • Faezeh Firuzpour,
  • Negin Shabihi,
  • Amirhossein Izadpanah,
  • Sahar Parkhideh,
  • Elham Roshandel,
  • Abbas Hajifathali,
  • Ahmad Gharehbaghian

摘要

Background

Acute myeloid leukemia (AML) remains a significant challenge in hematologic oncology, with high relapse rates and limited treatment options. Natural killer (NK) cells, as key effectors of innate immunity, have shown strong anti-leukemic activity, making them promising candidates for immunotherapy. Despite increasing clinical interest, a comprehensive evaluation of NK cell-based therapies in AML is still needed.

Methods

This systematic review follows the PRISMA guidelines to analyze clinical trials evaluating NK cell therapy in AML, either as a standalone treatment or in combination with hematopoietic stem cell transplantation (HSCT). A literature search across five major databases identified relevant studies, with data extraction focusing on NK cell sources, isolation and expansion strategies, clinical efficacy, and safety outcomes.

Results

A total of 48 clinical trials were identified, including 27 trials specific to AML and 21 trials involving AML along with other hematologic malignancies. Peripheral blood (PB)-derived NK cells were the main source (82%), with purification methods mainly using CliniMACS-based CD3 depletion and CD56 selection. Short-term activation (≤ 24 h) and long-term expansion (> 7 days) were employed in 36% of studies each. In non-HSCT transplant settings, NK cell therapy achieved a complete remission (CR) rate of 37.1% and an event-free survival (EFS) of 71.3%, while post-HSCT overall survival (OS) reached 39.5%. Notably, graft-versus-host disease (GVHD) incidence stayed low, highlighting the favorable safety profile of NK cell therapy.

Conclusion

NK cell-based therapy represents a promising and well-tolerated immunotherapeutic approach for AML. However, optimizing NK cell expansion, persistence, and clinical applications requires further investigation through large-scale, controlled trials.