CIML NK Cells for Leukemia

Not currently recruiting at 1 trial location

Overseen By Roman M. Shapiro, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Immunotherapy, BCR-ABL inhibitors

Disqualifiers: Autoimmune disease, Solid organ transplant, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using special immune cells called CIML NK cells, combined with IL-2, for patients with certain blood cancers like Acute Myeloid Leukemia (AML) who have relapsed after a stem cell transplant. The goal is to determine if these immune cells can fight the cancer more effectively. Suitable candidates have experienced a return or persistence of AML, MDS, or related conditions after a transplant and are free from certain other health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. For example, systemic GVHD medications like tacrolimus or sirolimus must be stopped 4 weeks before the cell infusion. Some other medications, like BCR-ABL inhibitors, need to be stopped 2 weeks before the infusion.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that CIML NK cells are safe for use in cancer treatments. Research indicates that these cells can be used without causing major side effects, such as cytokine release syndrome, a dangerous immune reaction. In one study, patients with acute myeloid leukemia (AML) received CIML NK cells and experienced complete remission without severe adverse events. Another study found that CIML NK cells led to remission in 47% of patients without serious complications. These findings suggest that CIML NK cells are generally well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for leukemia?

Most treatments for leukemia involve chemotherapy that targets rapidly dividing cells, but CIML NK cells work differently by harnessing the body's own immune system. CIML NK stands out because it uses cytokine-induced memory-like natural killer (NK) cells, which are a type of immune cell primed to attack cancer cells more effectively. Researchers are excited because these memory-like NK cells can potentially offer a more targeted approach, potentially leading to fewer side effects compared to traditional chemotherapy. Additionally, the use of CIML NK cells could provide faster and more durable responses in patients, offering new hope for those with leukemia.

What evidence suggests that CIML NK cells combined with IL-2 could be an effective treatment for leukemia?

Research has shown that CIML NK cells, which participants in this trial will receive, could help treat cancer. In one study, 67% of patients with acute myeloid leukemia (AML) who received CIML NK cells experienced significant symptom improvement, indicating a substantial reduction in their disease. Earlier studies also demonstrate that CIML NK cells are safe and effective in cancer treatment. When combined with other treatments, these cells have shown real promise in fighting leukemia. Overall, the evidence suggests that CIML NK cells could be an effective treatment option for some types of leukemia. ^{1 3 6 7 8}

Who Is on the Research Team?

Susanne Baumeister, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults and children (12+) with certain relapsed myeloid diseases after stem cell transplant can join. They need a willing original donor for cell collection, no recent severe GVHD treatments, and must use birth control. Excluded are those with autoimmune disease, active infections like hepatitis or HIV, recent other cancer treatments outside of specific exceptions, or uncontrolled illnesses.

Inclusion Criteria

I haven't taken any systemic treatments for GVHD in the last 4 weeks.

I can take care of myself and do some daily activities.

My disease is still present after stem cell transplant and it's been over 2 months.

Exclusion Criteria

I have had severe graft-versus-host disease or it's currently active and needs treatment.

I do not have autoimmune diseases like Crohn's, lupus, or rheumatoid arthritis, but Hashimoto's thyroiditis is okay.

I have received a solid organ transplant or a stem cell transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive Fludarabine and Cyclophosphamide as preparatory regimen

1 week

Daily visits for 3 days

Treatment

CIML NK cells are administered intravenously on day 0, followed by low-dose IL-2

6 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Regular visits up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• CIML NK
• Cyclophosphamide
• Fludarabine

Trial Overview The trial is testing CIML NK cells combined with IL-2 in patients who have had a relapse of AML, MDS or MPN after stem cell transplantation. It will evaluate the safety and effectiveness of this treatment approach in both adult and pediatric patients.

How Is the Trial Designed?

Group I: CIML NK Experimental Treatment 3 Interventions

* CIML NK cells will be administered intravenously on day 0. * Fludarabine will be administered as IV infusion once daily for 3 doses beginning on day -5. * Cyclophosphamide will be administered as IV infusion on days -5 and -4.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Rizwan Romee

Lead Sponsor

Trials

1

Recruited

50+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223015160

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 highlights the current ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12264592/

Cytokine-induced memory-like NK cells combined with ... Cytokine-induced memory-like NK cells combined with Tafasitamab demonstrate efficacy against B-cell acute lymphoblastic leukemia. Dimitrios ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8642969/

Cytokine-induced memory-like natural killer cells for cancer ... Recent proof toward the functionality of CIML NK cells in cancer is encouraging, and clinical data support the advantage of using CIML NK cells ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01898793

NCT01898793 | Cytokine-induced Memory-like NK Cells in ... This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid ...

5. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-020-00996-x

Natural killer cell-based immunotherapy for acute myeloid ... The first-in-human trial of adoptive transfer of CIML NK cells in elderly patients with R/R AML showed successful induction of remission (ORR 67 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35603208/

Cytokine-Induced Memory-Like NK Cells: From the Basics ... In relapse/refractory acute myeloid leukemia (AML), the adoptive transfer of CIML NK cells is safe and complete clinical remissions have been ...

7. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01669-3

First-in-human evaluation of memory-like NK cells with an IL ... CIML NK cells combined with N-803 and ipilimumab to treat head and neck cancer is safe, and associated with a more proliferative NK cell phenotype.

8. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.884648/full

Cytokine-Induced Memory-Like NK Cells: From the Basics ... Other report revealed that CIML NK cell therapy induced complete remission in 47% of patients without inducing cytokine release syndrome, graft- ...