Donor cells take on tough leukemia in early trial

NCT ID NCT04220684

Completed Disease control Sponsor: Sumithira Vasu Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the safety of giving donor natural killer (NK) cells to 19 patients with acute myeloid leukemia that had returned or not responded to treatment. Patients first received chemotherapy, then up to six infusions of specially grown NK cells from a donor. The main goal was to find a safe dose and watch for side effects, especially graft-versus-host disease.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: donor natural killer cells (KDS-1001) plus chemotherapy (cytarabine and fludarabine)
What this could lead to: If it works, this could point toward a new treatment option for patients with hard-to-treat acute myeloid leukemia.
What could go wrong: This is a very early (phase 1) safety trial with only 19 people, so it is not yet known if the treatment works. There are risks of serious side effects like graft-versus-host disease.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALLOGENEIC STEM CELL TRANSPLANT RECIPIENT BLASTS 10 PERCENT OR MORE OF BONE MARROW NUCLEATED CELLS RECURRENT ACUTE MYELOID LEUKEMIA REFRACTORY ACUTE MYELOID LEUKEMIA

Contacts and locations

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Oregon Health & Science University

Portland, Oregon, 24344, United States

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