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

Marina Konopleva; Vijaya Raj Bhatt; Ioannis Mantzaris; Abhishek Maiti; Krishna Gundabolu; Jolie Schafer; Kyle A. Jensen; Rao Saleem; Yi Li; Agata Drewniak; Pierre Bay; Winston W. Huh; Ozlem Yildirim; Giovanni Abbadessa; Sarah Cooley; Naval Daver

doi:10.1007/s00262-026-04333-y

April 11, 2026Cancer Immunology ImmunotherapyOpen 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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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

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Implication

Phase I trial demonstrates safety of off-the-shelf NK cell therapy in patients with relapsed or refractory AML, implying its clinical potential.

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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Konopleva et al. (2026) studied this question.

synapsesocial.com/papers/69dc88303afacbeac03ea124 https://doi.org/10.1007/s00262-026-04333-y

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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

Key Points

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Implication

Abstract

Discussion

Cite This Study

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

Key Points

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Implication

Abstract

Discussion

Cite This Study

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