What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include intensive combination chemotherapy and lower-intensity therapies. Intensive chemotherapy often leads to profound cytopenias, infections, and other complications requiring extended hospitalization. Lower-intensity treatments, while less toxic, can still cause side effects such as fatigue, nausea, and increased susceptibility to infections. Novel therapies like cytokine-induced memory-like natural killer (CIML-NK) cells are being studied for their ability to target and kill leukemia cells, but their side effects are still under investigation. Generally, these treatments aim to balance efficacy with manageable toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML) that target and kill leukemia cells. Hypomethylating agents like azacitidine and decitabine are commonly used, especially in patients who are not candidates for intensive chemotherapy. Targeted therapies include ivosidenib for IDH1 mutations and enasidenib for IDH2 mutations, both of which inhibit specific enzymes involved in the growth of leukemia cells. Venetoclax, often combined with hypomethylating agents or low-dose cytarabine, targets the BCL-2 protein to induce apoptosis in leukemia cells. These treatments, while not identical to CIML-NK cells, share the goal of targeting and eliminating leukemia cells.

What other types of research exist?

Promising novel alternatives to CIML-NK cells for treating AML in 2024 include: 1) CAR-T cell therapy, which involves engineering T cells to express chimeric antigen receptors targeting AML-specific antigens; 2) Bispecific T-cell engagers (BiTEs), which are designed to direct T cells to AML cells by binding to both T cells and AML-specific antigens; 3) FLT3 inhibitors, targeting the FLT3 mutation commonly found in AML patients; and 4) Venetoclax, a BCL-2 inhibitor that has shown efficacy in combination with other agents for treating AML.

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Virus Therapy

CIML-NK Cells for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Michele Wang

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using enhanced donor immune cells for patients with tough-to-treat leukemia. These special cells are designed to better remember and attack cancer cells. The goal is to see if this approach is safe and effective for these patients.

Who is the study for?

Adults diagnosed with relapsed or refractory acute myeloid leukemia (AML) who have a compatible family donor can join this trial. They must have at least 5% AML cells in their bone marrow and be able to perform daily activities at least half of the time. People with certain heart, lung, liver issues, uncontrolled infections, or on high-dose steroids cannot participate.

What is being tested?

The study is testing if natural killer cells treated with cytokines from a relative's donated cells are safe and effective for treating AML that has come back or hasn't responded to other treatments.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, as well as possible infusion-related reactions. The full range of side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of infusion

Secondary study objectives

Clinical Response to CIML-NK Infusion

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

Proceed to Hematopoietic Stem Cell Transplant (HSCT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cytokine-Induced Memory-Like Natural Killer (CIML-NK) CellsExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic agents to kill rapidly dividing cells, including leukemia cells, but can also harm normal cells, leading to significant side effects. Targeted therapies, such as FLT3 inhibitors, specifically target genetic mutations in leukemia cells, reducing damage to normal cells. Immunotherapy, including treatments like Cytokine-Induced Memory-Like Natural Killer (CIML-NK) cells, leverages the body's immune system to recognize and destroy leukemia cells. CIML-NK cells are particularly promising as they can be engineered to enhance their ability to target and kill leukemia cells, potentially leading to more effective and less toxic treatment options for AML patients.

Immunotherapy in AML: a brief review on emerging strategies.Epigenetic deregulation in myeloid malignancies.Can the New and Old Drugs Exert an Immunomodulatory Effect in Acute Myeloid Leukemia?