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Supercharged immune cells take on relapsed leukemia in new trial

NCT ID NCT03068819

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new approach for children and adults whose acute myeloid leukemia (AML) came back after a stem cell transplant. Researchers gave patients a special type of immune cell called cytokine-induced memory-like natural killer (CIML NK) cells, along with donor immune cells, to try to fight the leukemia. The goal was to see if this combination was safe and could help patients achieve remission. The trial enrolled 62 participants and looked at both safety and how well the treatment worked.

What this could mean

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

Active substance
Cytokine-induced memory-like natural killer (CIML NK) cells
What this could lead to
If this works, it could offer a more effective treatment for patients whose leukemia returns after a stem cell transplant, potentially improving remission rates and survival.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. There are risks of graft-versus-host disease, infections, and other side effects from the cell infusions.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

62 people

The number who actually took part.

Started

Oct 2017

Finished

Jun 2025

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: * Relapsed AML after HLA-matched related or unrelated allogeneic hematopoietic cell transplant * For pilot pediatric/young adult patient cohort ≥1 and \<18 years of age * For phase 2 adult patient cohort ≥18 years of age * Available original donor (same donor as used for the initial stem cell transplant) that is willing and eligible for non-mobilized collection * Patients with known central nervous system (CNS) involvement with AML are eligible provided that they have been treated and cerebrospinal fluid (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 * Not currently requiring systemic corticosteroid therapy (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) or any other immune suppressive medications * 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 including throughout the initial evaluation period (100 days after CIML NK cell infusion). * 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: * Acute or chronic GvHD with ongoing active systemic treatment. * Circulating blast count \>10,000/uL by morphology or flow cytometry (cyto-reductive therapies, including salvage chemotherapy, is encouraged prior to study enrollment) * Uncontrolled bacterial or viral infections, or known HIV, Hepatitis B, or Hepatitis C infection. * Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities. * New or progressive pulmonary infiltrates concerning for new or uncontrolled infectious process. * Known hypersensitivity to one or more of the study agents * Received any investigational drugs within the 14 days prior to CIML NK cell infusion date * Pregnant and/or breastfeeding Donor Inclusion Criteria: * At least 18 years of age * Same donor as used for the allo-HCT * In general good health, and medically able to tolerate leukapheresis * Ability to understand and willingness to sign an IRB approved written informed consent document Donor Exclusion Criteria: * Active hepatitis, positive for HTLV, or HIV on donor viral screen * Pregnant

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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.