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April 13, 2026Cancer Immunology Immunotherapy0 citationsOpen Access

A phase I, single-arm, open-label, dose-escalation, multicenter study of SAR445419, an off-the-shelf, ex vivo expanded allogeneic natural killer cell product, in participants with relapsed or refractory acute myeloid leukemia

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MKMarina KonoplevaVBVijaya Raj BhattIMIoannis Mantzaris

Key Points

  • To assess the safety of ex vivo expanded allogeneic NK cells in patients with relapsed or refractory acute myeloid leukemia.
  • Phase I, single-arm, open-label design
  • Participants received off-the-shelf NK cells
  • Dose-escalation approach was employed
  • Demonstrated overall safety of the NK cell product
  • Feasibility of manufacturing and distribution was confirmed
  • Further improvements in clinical efficiency are needed

Abstract

This study demonstrated the overall safety of off-the-shelf ex vivo expanded allogeneic NK cells in patients with R/R AML. The successful manufacturing and distribution support the feasibility of donor-derived off-the-shelf NK cells in a clinical setting. Further investigations are required to improve the clinical efficiency of NK cells.

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Cite This Study

Konopleva et al. (2026) studied this question.

synapsesocial.com/papers/69dc88303afacbeac03ea124https://doi.org/10.1007/s00262-026-04333-y
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