Supercharged immune cells aim to beat back tough leukemia
NCT ID NCT02782546
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving patients with hard-to-treat acute myeloid leukemia (AML) a special type of immune cell—called a cytokine-induced memory-like natural killer (NK) cell—after a stem cell transplant can improve their chances of staying cancer-free. About 60 adults with AML that did not respond to standard treatments will receive a donor stem cell transplant followed by these memory-like NK cells. The goal is to see if this combination can boost leukemia-free survival at 100 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- memory-like natural killer (NK) cells
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat acute myeloid leukemia, potentially improving their chances of staying cancer-free.
- What could go wrong
- This is an early-phase trial with only 60 participants, so results may not apply to everyone. There are risks of graft failure, severe graft-versus-host disease, or the treatment not working as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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60 people
The number who actually took part.
- Started
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Jan 2017
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Recipient Inclusion Criteria: * Refractory AML without complete remission (CR) after 2 or more cycles of induction therapy (primary induction failure), or AML relapsed after obtaining a CR and failed one or more cycles of re-induction therapy. Standard dose 10-day decitabine (20 mg/m2 daily IV x 10 days) or 7-day azacitidine (75-100 mg/m2 daily SC/IV x 7 days) will be considered as one cycle of induction therapy. * At least 18 years of age * Available HLA-haploidentical donor that meets the criteria in the protocol * Patients with known CNS involvement with AML are eligible provided that they have been treated and CSF is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment. * Karnofsky performance status \> 60 % * Adequate organ function as defined below: * Total bilirubin \< 2 mg/dl * AST(SGOT)/ALT(SGPT) \< 3.0 x IULN * Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m2 by Cockcroft-Gault Formula * Oxygen saturation ≥90% on room air and adjusted DLCO of at least 40% * Ejection fraction ≥40% * Able to be off of corticosteroids (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) and any other immune suppressive medications beginning on Day -3 * Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration. Female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study and throughout the DLT evaluation period. * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Recipient Exclusion Criteria: * Relapsed after allogeneic transplantation. * Circulating blast count \>30,000/uL by morphology or flow cytometry (cyto-reductive therapies including leukapheresis or hydroxyurea are allowed). * Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B or C infection. * Presence of donor specific antibodies (DSA) with Mean Fluorescence Intensity (MFI) of \>5000 as assessed by the single antigen bead assay, \< 6 weeks prior to starting transplant conditioning * Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities. * New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that have not been evaluated with bronchoscopy. Infiltrates attributed to infection must be stable/ improving after 1 week of appropriate therapy (4 weeks for presumed or proven fungal infections) * Known hypersensitivity to one or more of the study agents * Received any investigational drugs within the 14 days prior to the first day of transplant conditioning * Pregnant and/or breastfeeding Donor Inclusion Criteria: * Related donor (sibling, offspring, or offspring of sibling) * At least 18 years of age * HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus. * In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study. * Ability to understand and willingness to sign an IRB approved written informed consent document Donor Exclusion Criteria: * Positive for hepatitis, HTLV, or HIV infection * Pregnant and/or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a drug and donor cells stop leukemia from returning after transplant?
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