Actively Recruiting
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-02-25
20
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial 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 efficacy of the CIML-NK cells in treating AML.
CONDITIONS
Official Title
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 years or older at study enrollment
- Diagnosis of AML according to 2016 WHO criteria
- Relapsed or refractory AML in the bone marrow
- Refractory disease defined as at least 5% blasts in bone marrow after 2 courses of intensive induction treatment
- Relapsed disease defined as at least 5% blasts in bone marrow or reappearance of blasts in blood within 6 months of initial complete remission
- Availability of haploidentical related donor; donor specific antibody testing will be performed
- Performance level of 50% or higher on Karnofsky scale if older than 16 years, or 50% or higher on Lansky scale if 16 years or younger
You will not qualify if you...
- Isolated central nervous system disease or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia; extramedullary disease combined with bone marrow disease allowed
- Active uncontrolled infection
- Systolic ejection fraction less than 45% by echocardiogram
- Oxygen saturation below 92% on room air
- Total bilirubin greater than 2 mg/dL or AST/ALT more than three times the upper limit of normal
- Receiving more than 10 mg prednisone equivalent daily or more than 0.5 mg/kg prednisone equivalent daily, whichever is less
- Receiving other investigational therapies
- Known allergy or hypersensitivity to IL-2 injections
- Pregnant or breastfeeding women; females and males of reproductive potential must agree to use effective contraception during treatment and for six months after
- Effective contraception methods include oral contraceptives, patches, injections, intrauterine devices, tubal ligation, partner vasectomy, or abstinence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
Z
Zahra Hudda
CONTACT
C
Caitlin Cottrell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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