CIML NK Cells for Leukemia
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.12345
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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Treatment
Participants receive Fludarabine and Cyclophosphamide as preparatory regimen
Treatment
CIML NK cells are administered intravenously on day 0, followed by low-dose IL-2
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
* 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Rizwan Romee
Lead Sponsor
The Leukemia and Lymphoma Society
Collaborator
Citations
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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.
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- ...
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