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CIML-NK Cells for Relapsed or Refractory Acute Myeloid Leukemia

This study is testing a new treatment called Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK cells) for people with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to other treatments (refractory). These CIML-NK cells are made from a donor's blood and are designed to help fight the cancer. The main goal is to see if these cells can be given safely to patients. Researchers also want to see if the CIML-NK cells are effective in treating AML. You might be able to join if you are at least 2 years old and have relapsed or refractory AML. The study aims to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will receive a chemotherapy regimen to prepare their body, followed by an infusion of CIML-NK cells. The feasibility of the infusion will be measured at 30 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, feasibility of infusion, is measured at 30 days after the infusion.

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NCT05580601

Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)

Recruiting
PHASE1Ages 2+InterventionalTreatment
Children's Hospital Medical Center, Cincinnati
~20 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:CIML-NK Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of infusion
Measured over 30 days

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Zahra Hudda · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Zahra Hudda
[email protected]
917-754-7118
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Of age ≥ 2 years of age at the time of study enrollment
With AML diagnosed per 2016 WHO criteria (11)
With relapsed or refractory AML in their bone marrow
Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment
Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR
With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment.
With performance level of ≥ 50% on Karnofsky scale for patients \> 16 years of age and ≥ 50% on Lansky scale for patients ≤ 16 years of age

Exclusion

Disease: isolated central nervous system (CNS) disease, or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia (APML). Patients with extramedullary disease in combination with bone marrow disease are eligible for enrollment.
Infectious Disease: Active uncontrolled infection
Cardiac function: Systolic ejection fraction \<45% by echocardiogram
Pulmonary Function: Oxygen saturation \<92% on room air
Hepatic function: Total bilirubin \> 2mg/dL, AST and ALT more than three times the upper limit of normal
Concomitant medications: receiving either \>10mg prednisone equivalent daily, or \>0.5mg/kg prednisone equivalent daily, whichever is less
Concomitant investigational treatments: receiving other investigational therapies
Known allergy or hypersensitivity reaction to IL-2 injections
Pregnant or breastfeeding women will not be entered on this study due to risks of fetal and teratogenic adverse events with lymphodepleting chemotherapy. Pregnancy tests must be obtained for female patients. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion. Effective contraceptive methods include oral contraceptive pills, patches, or injections, intrauterine devices, having a tubal ligation, having a partner who has had a vasectomy, or not having sex.

What this trial measures

  • Feasibility of infusion30 days

    Number of patients who receive CIML-NK infusion without grade 3-4 infusional toxicity events as assessed by CTCAE v5.0 divided by the number of patients enrolled.