NCT05580601RecruitingPhase 1/2
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 Oct 2022
- Start date
- 5 May 2023
- Primary completion date
- Jan 2027
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT05580601
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 5 May 2023 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- 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
- Known allergy or hypersensitivity reaction to IL-2 injections
Lab values
- Cardiac function: Systolic ejection fraction \<45% by echocardiogram
- Hepatic function: Total bilirubin \> 2mg/dL, AST and ALT more than three times the upper limit of normal
Other
- Pulmonary Function: Oxygen saturation \<92% on room air
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.