18 Participants NeededMy employer runs this trial

AdaptNK for Acute Myeloid Leukemia

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Masonic Cancer Center, University of Minnesota
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?

This trial explores a new treatment called AdaptNK for individuals with acute myeloid leukemia (AML) that has returned or isn't responding to other treatments. AdaptNK employs special immune cells known as natural killer (NK) cells, enhanced by a short course of a protein called interleukin-2 (IL-2), to combat cancer after chemotherapy. The trial will test various doses of AdaptNK to determine the safest and most effective amount. Suitable candidates have AML that hasn't responded to other treatments and aren't currently using certain immune-suppressing medications. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications. You must be off glucocorticoids and other immunosuppressive medications for at least 28 days before the NK cell infusion. Additionally, there are specific time requirements for stopping other treatments like chemotherapy and targeted agents before joining the trial.

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

Research has shown that treatments using natural killer (NK) cells, such as AdaptNK, are generally safe for patients with acute myeloid leukemia (AML). In studies, patients receiving NK cell therapies have experienced few serious side effects. The most common issues include mild flu-like symptoms, such as fever or chills, which can be managed.

One study focused on finding the safest dose of AdaptNK and found it safe at certain levels without major side effects. Another study demonstrated that NK cells from donors could help treat relapsed AML and were safe to use.

Overall, while researchers continue to study NK cell therapies, current evidence suggests they are safe for people, with manageable side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about AdaptNK for treating Acute Myeloid Leukemia (AML) because it represents a novel approach using natural killer (NK) cells. Unlike traditional treatments for AML, such as chemotherapy and stem cell transplants, AdaptNK uses a targeted form of immunotherapy that harnesses the body's own immune system to attack cancer cells. This method involves administering a specific number of Total Nucleated Cells (TNC) intravenously, which could potentially improve the precision and reduce the side effects compared to broader, less targeted treatments. By focusing on enhancing the immune response, AdaptNK offers a promising alternative with the potential for greater efficacy and safety in managing AML.

What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?

Studies have shown that AdaptNK, a therapy using natural killer (NK) cells, can effectively target acute myeloid leukemia (AML) cells. Research indicates that these NK cells, strengthened by exposure to the common virus human cytomegalovirus (CMV), can fight leukemia cells in both laboratory and patient settings. Specifically, trials using NK cell therapy have demonstrated a significant chance of achieving remission in some patients with AML. Data reveals that for patients with low to intermediate-risk AML who are in remission, there is an 82% chance of staying disease-free for one year. Overall, NK cell therapies show promise as a new way to combat this challenging type of leukemia. Participants in this trial will receive varying doses of the AdaptNK product to evaluate its safety and effectiveness.12356

Are You a Good Fit for This Trial?

This trial is for people with acute myeloid leukemia (AML) that has come back or hasn't responded to treatment. Participants should be eligible for a stem cell transplant and able to receive chemotherapy.

Inclusion Criteria

I have not taken steroids or immune-suppressing drugs for GVHD in the past 28 days.
My HLA type is C1/C1 or C2/C2.
My liver, kidneys, lungs, and heart are working well.
See 14 more

Exclusion Criteria

I have an inflammatory disease that needs immunosuppressive medication.
My myeloid cancer is not linked to inherited genes, except DDX41, TP53, or RUNX1.
Pregnant or breastfeeding
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine

1 week

Treatment

Participants receive an infusion of AdaptNK cells and a short course of subcutaneous interleukin-2 (IL-2)

6 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • AdaptNK
  • Cyclophosphamide
  • Fludarabine
  • Interleukin-2 (IL-2)

Trial Overview

The study tests an infusion of special donor immune cells called AdaptNK, along with IL-2 injections, after patients get chemotherapy drugs fludarabine and cyclophosphamide. The goal is to prepare patients for a future stem cell transplant.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Dose Level Cohort 3Experimental Treatment4 Interventions
Group II: Dose Level Cohort 2Experimental Treatment4 Interventions
Group III: Dose Level Cohort 1Experimental Treatment4 Interventions
Group IV: Dose Level Cohort -1Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials
285
Recruited
15,700+

Citations

Adoptive NK cell therapy in AML: progress and challenges

These therapies have demonstrated varying degrees of therapeutic efficacy, ranging from transient anti-leukemia activity to sustained remission ...

NK cell adoptive transfer in acute myeloid leukemia

In low-/intermediate-risk AML in remission (3 studies; 38 patients), pooled 1-year DFS was 82% (95% CI 56–100; I²=0). In high-risk AML in remission and ...

Adaptive single-KIR + NKG2C + NK cells expanded from ...

We investigated the functional responses of ADAPT-NK cells against a wide range of tumor target cell lines and primary AML samples using flow cytometry and ...

Adapt NK for High Risk Myeloid Diseases as Bridge to Allo ...

The primary objective of the study is to assess the safety and determine the maximum tolerated dose (MTD) of AdaptNK administered as a single ...

Outcomes with intensive treatment for acute myeloid ...

While survival of AML elderly patients remains poor, patients ≥60 years old overall have a 20% survival benefit at 5 years if they receive an ...

CAR-NK cell therapy in acute myeloid leukemia

It accounts for 80% to 85% of adult acute leukemias and carries a 5-year survival rate of only 23% to 33% in North America (Canadian Cancer Society, ...