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Background <p>Relapse is a major cause of treatment failure in high-risk acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HSCT). Natural killer (NK) cell immunotherapy may enhance graft-versus-leukemia (GvL) effects without increasing graft-versus-host disease (GvHD). This study assessed the safety and feasibility of early post-HSCT prophylactic infusions of third-party NK cells in high-risk AML.</p> Methods <p>In a single-arm, non-randomized trial, 11 high-risk AML patients received two doses of ex vivo expanded third-party NK cells (5 × 10⁶ cells/kg) on days 6 and 12 post-HSCT. Endpoints included safety (CTCAE v5.0), relapse incidence, overall survival (OS), and disease-free survival (DFS). NK cell products were assessed for purity (≥ 80% CD56⁺CD3⁻), cytotoxicity (K562 assay), and expansion.</p> Results <p>NK cell infusion was well tolerated, with no grade 3 or higher infusion-related toxicities. Acute GvHD (Grade 1–2) occurred in 36.4% (4/11); chronic GvHD in 27.3% (3/11). CMV reactivation occurred in 45.5% (5/11) and was managed preemptively. At a median 256-day follow-up (54–514), Relapse occurred in 27.3% (3/11; median: 111 days). Survival was significantly better in patients in CR1/CR2 at HSCT (83.3%) compared to those not in remission (20%; <i>p</i> = 0.02).</p> Conclusion <p>Early prophylactic NK cell infusions post-HSCT are safe and feasible. Although relapse incidence remains substantial, outcomes appear improved versus historical data. Future randomized trials must confirm clinical benefits and refine timing/dosing strategies.</p>

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Evaluating the safety and feasibility of prophylactic third-party NK cell administration in high-risk AML patients post-HSCT

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月22日

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  • Maryam Barkhordar,
  • Shima Tavoosi,
  • Shirin Tavakoli,
  • Maryam Samareh Salavatipour,
  • Tanaz Bahri,
  • Bahram Chahardouli,
  • Amir Hossein Baghsheikhi,
  • Mohammad Vaezi,
  • Davoud Babakhani,
  • Soroush Rad,
  • Seied Asadollah Mousavi,
  • Ghasem Janbabai,
  • Hossein Salehi-Shadkami,
  • Mohammad Ahmadvand

摘要

Background

Relapse is a major cause of treatment failure in high-risk acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HSCT). Natural killer (NK) cell immunotherapy may enhance graft-versus-leukemia (GvL) effects without increasing graft-versus-host disease (GvHD). This study assessed the safety and feasibility of early post-HSCT prophylactic infusions of third-party NK cells in high-risk AML.

Methods

In a single-arm, non-randomized trial, 11 high-risk AML patients received two doses of ex vivo expanded third-party NK cells (5 × 10⁶ cells/kg) on days 6 and 12 post-HSCT. Endpoints included safety (CTCAE v5.0), relapse incidence, overall survival (OS), and disease-free survival (DFS). NK cell products were assessed for purity (≥ 80% CD56⁺CD3⁻), cytotoxicity (K562 assay), and expansion.

Results

NK cell infusion was well tolerated, with no grade 3 or higher infusion-related toxicities. Acute GvHD (Grade 1–2) occurred in 36.4% (4/11); chronic GvHD in 27.3% (3/11). CMV reactivation occurred in 45.5% (5/11) and was managed preemptively. At a median 256-day follow-up (54–514), Relapse occurred in 27.3% (3/11; median: 111 days). Survival was significantly better in patients in CR1/CR2 at HSCT (83.3%) compared to those not in remission (20%; p = 0.02).

Conclusion

Early prophylactic NK cell infusions post-HSCT are safe and feasible. Although relapse incidence remains substantial, outcomes appear improved versus historical data. Future randomized trials must confirm clinical benefits and refine timing/dosing strategies.