Supercharged immune cells take on relapsed leukemia in new trial
NCT ID NCT03068819
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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62 people
The number who actually took part.
- Started
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Oct 2017
- Finished
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Jun 2025
- 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: * 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
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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