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Supercharged immune cells aim to beat back tough leukemia

NCT ID NCT02782546

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Jan 2017

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • 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.