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

NCT05580601 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2020-0853
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of infusion

  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.

  30 days

Secondary Outcomes (3)

• Clinical Response to CIML-NK Infusion

  30 days

• Persistence of CIML-NK cells in the recipients' peripheral blood

  Assessed at day 7, 14, 21, 28

• Proceed to Hematopoietic Stem Cell Transplant (HSCT)

  6 months

Study Arms (1)

Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells

EXPERIMENTAL

The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product.

Drug: CIML-NK Cells

Interventions

CIML-NK Cells DRUG

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.

Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zahra Hudda

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Hudda

CONTACT

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

Caitlin Cottrell

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 14, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)