Recruiting
Phase 1
Phase 2

CIML-NK

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05580601

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

CIML-NK Cells

Study Details

Brief summary:

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

Acute Myeloid Leukemia

Study ID

NCT05580601

Start date

May 5, 2023

Status verified date

Feb, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cytokine-Induced Memory-Like Natural Killer (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.

Interventions

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 measure

  • Feasibility of infusion [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Zahra Hudda

917-754-7118Zahra.Hudda@cchmc.org

Caitlin Cottrell

513-803-7039Caitlin.cottrell@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Caitlin Cottrell

Caitlin.cottrell@cchmc.org

Richard Cooper

richard.cooper@cchmc.org

Principal Investigator:

Michele Wang, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-25.