NCT05580601 · Children's Hospital Medical Center, Cincinnati
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
What this study is about
The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess effectiveness of the CIML-NK cells in treating AML.
View original scientific description
The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.
Interventions
DRUG
CIML-NK Cells
The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product. At the time of infusion, the product is comprised of: * Cytokine-Induced Memory-Like NK cells (CIML-NK cells) * Human Serum Albumin * Plasmalyte The concentration and total cell number of CIML-NK cells in the product will vary based on the recipient body weight and the dose requested.
Primary outcome measures
Feasibility of infusion
Time frame: 30 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations