20 Participants NeededMy employer runs this trial

CIML-NK Cells for Neuroblastoma

CC
Overseen ByCaitlin Cottrell, BSN, RN
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using cytokine-induced memory-like natural killer cells (CIML-NK cells) to combat neuroblastoma. Neuroblastoma, a cancer affecting nerve tissues, can be difficult to treat with standard methods. The study will determine if these cells can be safely infused into patients with relapsed or hard-to-treat neuroblastoma while they receive the drug dinutuximab. Individuals with a confirmed diagnosis of high-risk neuroblastoma that has returned or is unresponsive to standard treatments may qualify for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that cytokine-induced memory-like natural killer cells are likely to be safe for humans?

In a previous study, researchers found that a type of immune cell called memory-like natural killer cells was safe for cancer treatment. Research shows that patients can receive these cells without experiencing serious side effects. Some patients even saw their cancer symptoms completely disappear. These findings suggest that these immune cells might be well-tolerated by people with cancer, including those with neuroblastoma.12345

Why do researchers think this study treatment might be promising for neuroblastoma?

Researchers are excited about CIML-NK Cells for treating neuroblastoma because they offer a novel approach compared to existing therapies like chemotherapy, radiation, and surgery. Unlike these standard treatments, CIML-NK Cells are derived from a donor's immune cells and are specially modified to remember and attack cancer cells more effectively. This memory-like capability potentially enhances the body's natural ability to fight the cancer, offering hope for improved outcomes in children with neuroblastoma.

What evidence suggests that CIML-NK cells might be an effective treatment for neuroblastoma?

Research has shown that a special type of immune cell, called cytokine-induced memory-like natural killer (CIML-NK) cells, may help treat cancer. In studies, these cells effectively controlled tumor growth, particularly in animal models of diseases like acute myeloid leukemia (AML) and multiple myeloma. They enhance the body's natural ability to fight cancer cells and possess a longer lifespan with a stronger capacity to kill cancer cells. Early reports from cancer trials suggest these cells can be safe and may help reduce cancer. Although more research is needed, these early results are promising for conditions like neuroblastoma. Participants in this trial will receive CIML-NK cells to evaluate their effectiveness and safety in treating neuroblastoma.24567

Who Is on the Research Team?

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Christopher Dandoy, MD, MS

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for people aged 1 to 39 with high-risk neuroblastoma that has come back, gotten worse, or not responded to standard treatment. Participants must have measurable disease and be well enough (performance score over 50%) to take part.

Inclusion Criteria

2. One or more MIBG, FDG, or 68Ga-DOTATATE avid bone lesion
I am able to care for myself and do daily activities despite my illness.
I have been diagnosed with neuroblastoma confirmed by a tissue test.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cytokine-induced memory-like natural killer cells (CIML-NK) during dinutuximab-based therapy

8 weeks
Multiple visits for infusions and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study is testing the safety of giving special immune cells called CIML-NK cells from a donor, along with usual dinutuximab therapy, in patients with relapsed or hard-to-treat neuroblastoma.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Citations

Cytokine-induced memory-like natural killer cells exhibit ...

Human memory-like NK cells xenografted into mice substantially reduced AML burden in vivo and improved overall survival. Clinical responses ...

Cytokine-Induced Memory-Like NK Cells: From the Basics ...

CIML NK cells also showed an effective control of tumor growth in a mouse model of multiple myeloma (66). Strikingly, therapeutic effects of IL- ...

Haploidentical Donor Cytokine-Induced Memory-Like ...

The goal of this study is to demonstrate that cytokine-induced memory-like natural killer cells (CIML-NK cells) can be generated from donor cells

Cytokine-Induced Memory-Like Natural Killer Cell Therapy ...

Giving CIML NK with interleukin-2 may be safe, tolerable and/or effective in treating patients with AML or MDS with measurable residual disease.

Review Cytokine‐Induced Memory‐Like NK Cells

Previous studies documented that using CIML-NK cells in cancer treatment is safe and results in promising outcomes. This review

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34863287/

Cytokine-induced memory-like natural killer cells for cancer ...

Preclinical studies and very early clinical trials demonstrate safety and very promising clinical activity of these cytokine-induced memory-like ...

Cytokine-Induced Memory-Like Natural Killer Cells (CIML ...

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 ...