15 Participants Needed

NK Cell Therapy for Acute Myeloid Leukemia

Recruiting at 1 trial location
RS
Overseen ByRoman Shapiro, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Dana-Farber Cancer Institute
Must be taking: Interleukin-2
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.Names of the study therapies involved in this study are:* CIML NK cells intravenous infusion (cellular therapy)* Subcutaneous Interleukin-2 (recombinant, human glycoprotein)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that certain therapies, like BCR-ABL inhibitors, must be stopped at least 2 weeks before the NK cell infusion. It's best to discuss your specific medications with the study team.

Is NK cell therapy safe for humans?

Research shows that using cytokine-induced memory-like (CIML) NK cells in cancer treatment, including for acute myeloid leukemia (AML), is considered safe and has resulted in promising outcomes.12345

How is the NK Cell Therapy for Acute Myeloid Leukemia different from other treatments?

This treatment uses cytokine-induced memory-like natural killer (CIML NK) cells, which are enhanced by a brief preactivation with specific proteins (IL-12, IL-15, and IL-18) to improve their ability to fight leukemia cells. Unlike conventional treatments, these NK cells have a memory-like function that allows them to persist and remain active for a longer time, potentially leading to better outcomes in patients with acute myeloid leukemia.36789

What data supports the effectiveness of the treatment Cytokine Induced Memory-like Natural Killer Cells for Acute Myeloid Leukemia?

Research shows that Cytokine Induced Memory-like Natural Killer Cells (CIML NK cells) have enhanced ability to fight leukemia cells and improve survival in animal models. In a clinical trial, these cells led to complete remission in some patients with acute myeloid leukemia, indicating promising results for this treatment.23679

Who Is on the Research Team?

RS

Roman Shapiro, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older with newly diagnosed acute myeloid leukemia (AML), those in first complete remission but still have detectable disease, and patients with secondary AML, therapy-related MDS/AML, or certain types of myelodysplastic syndrome (MDS). Participants must have acceptable bilirubin levels unless due to Gilbert's syndrome or hemolysis.

Inclusion Criteria

I have been diagnosed with MDS/MPN or CMML.
I have acute myeloid leukemia in first complete remission and minimal residual disease detected.
Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease related hemolysis, then < 3 x ULN)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive standard-of-care conditioning chemotherapy and stem cell infusion followed by CIML NK cells and Interleukin-2 infusions

6 weeks
Multiple visits for infusions and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for GVHD and disease progression

1 year
Regular visits for assessments

Long-term Follow-up

Participants are monitored for long-term outcomes such as overall survival and progression-free survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cytokine Induced Memory-like Natural Killer Cells
  • Interleukin-2
Trial Overview The study tests CIML NK cell infusions combined with Interleukin-2 injections to prevent cancer relapse in patients who've had a stem cell transplant for AML, MDS, or overlap syndromes. It aims to determine the safety and effectiveness of this approach.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Phase 1/1b: CIML NK Cells + Interleukin-2Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Published Research Related to This Trial

Cytokine-induced memory-like NK cells show enhanced ability to produce interferon-γ and kill leukemia cells, making them a promising option for treating acute myeloid leukemia (AML).
In a first-in-human phase 1 clinical trial, memory-like NK cells were successfully expanded in AML patients, leading to clinical responses in five out of nine patients, including four complete remissions, indicating their potential effectiveness as an immunotherapy.
Cytokine-induced memory-like natural killer cells exhibit enhanced responses against myeloid leukemia.Romee, R., Rosario, M., Berrien-Elliott, MM., et al.[2021]
Cytokine-induced memory-like (CIML) NK cells, which are generated through brief stimulation with IL-12, IL-15, and IL-18, show enhanced effector functions and long-term persistence, making them promising candidates for cancer immunotherapy.
Clinical trials have demonstrated that infusions of CIML NK cells are safe and have led to complete clinical remissions in patients with relapse/refractory acute myeloid leukemia (AML).
Cytokine-Induced Memory-Like NK Cells: From the Basics to Clinical Applications.Terrén, I., Orrantia, A., Astarloa-Pando, G., et al.[2022]
In a clinical trial involving 15 patients with relapsed/refractory acute myeloid leukemia (AML), the use of donor-derived memory-like (ML) NK cells combined with N-803 (an IL-15 superagonist) was well tolerated and resulted in an impressive 87% of patients achieving a composite complete response within 28 days.
The ML NK cells showed significant expansion and persistence, remaining the dominant lymphocyte population for over 2 months post-transplant, and exhibited enhanced antitumor functions compared to conventional NK cells, indicating their potential as an effective immunotherapy strategy.
Hematopoietic cell transplantation donor-derived memory-like NK cells functionally persist after transfer into patients with leukemia.Berrien-Elliott, MM., Foltz, JA., Russler-Germain, DA., et al.[2023]

Citations

Cytokine-induced memory-like natural killer cells exhibit enhanced responses against myeloid leukemia. [2021]
Cytokine-Induced Memory-Like NK Cells: From the Basics to Clinical Applications. [2022]
Hematopoietic cell transplantation donor-derived memory-like NK cells functionally persist after transfer into patients with leukemia. [2023]
Cytokine-induced killer cells for cell therapy of acute myeloid leukemia: improvement of their immune activity by expression of CD33-specific chimeric receptors. [2021]
Cytokine-Induced Memory-Like NK Cells: Emerging strategy for AML immunotherapy. [2023]
A phase I/II clinical trial of autologous cytokine-induced killer cells as adjuvant immunotherapy for acute and chronic myeloid leukemia in clinical remission. [2022]
Cytokine-induced killer cells: A novel immunotherapy strategy for leukemia. [2020]
Enhanced expression of natural cytotoxicity receptors on cytokine-induced memory-like natural killer cells correlates with effector function. [2023]
Expanded clinical-grade membrane-bound IL-21/4-1BBL NK cell products exhibit activity against acute myeloid leukemia in vivo. [2021]
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