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Acute Myeloid Leukemia RefractoryPhase 1NCT07011004

A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia

A Phase 1 study testing Cytokine Induced Memory-Like Natural Killer Cells, Atezolizumb and CIML-NK cell therapy in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia, in Relapse, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed/refractory acute myelogenous leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Cytokine Induced Memory-Like Natural Killer Cells, Atezolizumb and CIML-NK cell therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
7 sitesUnited States
Study dates
30 May 2025to May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease specific inclusion criteria:
  • Subjects must have histologically confirmed acute myeloid leukemia that meets any of the following criteria:
  • Refractory to at least two attempts at prior induction therapy. An attempt is defined as either a single cycle of combination chemotherapy such as daunorubicin/anthracycline OR a single monthly cycle of a hypomethylating agent with venetoclax.
  • Patients with FLT3-ITD or -TKD mutations must have received at least one commercially available inhibitor of FLT3.
  • Patients with NPM1 mutation or rearrangements of MLL must be refractory to revumenib.
  • Patients with mutations in IDH1 or IDH2 must be refractory to at least one commercially available inhibitor of IDH1 or IDH2, respectively.
Show all 27Show fewer
  • Relapsed AML when relapse occurred within 6 months of achieving an initial complete remission.
  • Patients must have either failed prior FDA approved agents or, in the opinion of the treating physician, have a sufficiently low probability of response to existing FDA approved agents to warrant treatment on an investigational protocol.
  • Other inclusion criteria:
  • Patients aged 18 through 70 years old are eligible.
  • Must have an available, haplotype mismatched related individual that meets criteria for cell donation according to the FACT guidelines.
  • Patients must have Karnofsky performance status ≥70%.
  • Adequate cardiac function as defined as a systolic LV ejection fraction ≥50% at rest and absence of New York Heart Association stage III or IV congestive heart failure.
  • Adequate pulmonary function as defined as a resting SpO2 ≥ 92% on room air at rest.
  • Serum bilirubin ≤ 5 mg/dL.
  • AST and ALT ≤ 2.5x ULN unless thought to be disease related.
  • Estimated or measured creatinine clearance > 50 mL/min.
  • Subjects must be free from all systemic immune suppression for at least 4 weeks prior to the start of intended therapy.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.
  • Negative HIV test at screening.
  • Negative hepatitis B surface antigen (HBsAg) test at screening OR positive HBsAg is allowed if a negative HBcAb or a negative quantitative hepatitis B virus (HBV) (DNA < 500 IU/mL) assay are documented.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.
  • For patients receiving therapeutic anticoagulation: Stable anticoagulant regimen for 2 weeks prior to enrollment.
  • Timing of treatment relative to prior therapies:
  • Bridging therapy with hydrea is allowed but is required to be tapered off prior to NK infusion.
  • Any experimental biological treatments must be discontinued for at least 5 half-lives prior to initiation of study therapy.
  • Patients must be >5 half-lives from receipt of other cytotoxic or targeted therapy.

Who cannot join

  • Prior allogeneic hematopoietic cell transplantation.
  • Subjects with active/uncontrolled CNS leukemia. Subjects with prior CNS disease must have no detectable evidence of CSF disease for at least 4 weeks prior to enrollment.
  • Subjects requiring systemic immunosuppression for any indication are excluded.
  • Significant cardiovascular disease, as defined by:
  • New York Heart Association Class II or greater congestive heart failure.
  • Myocardial infarction, cerebrovascular accident, or other arterial vascular disease within 6 months prior to initiation of study treatment
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  • Unstable arrhythmia
  • Unstable angina
  • Subjects with isolated extramedullary disease without evidence of bone marrow involvement by immunohistochemistry.
  • Female patients who are pregnant or breast-feeding or intend to become pregnant during study treatment or within 5 months after the final dose of atezolizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment with atezolizumab.
  • Severe or uncontrolled infection prior to initiation of study treatment.
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, excluding prophylactic antimicrobial agents.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium >12 mg/dL, or corrected calcium greater than ULN)
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, anti-phospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:
  • Rash must cover < 10% of body surface area.
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
  • There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Persons who do not meet the age and organ function criteria specified above.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
  • Donor Inclusion Criteria:
  • Donors must be eligible for apheresis according to standard FACT guidelines.
  • Donors must not have an HLA genotype reactive against anti-HLA antibodies in the recipient.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brian Shaffer, MD contact

646-608-2091

ABMTTrials@mskcc.org

Mark Geyer, MD contact

646-608-3745

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Brian Shaffer, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

    Commack, New York, 11725

    Brian Shaffer, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

    Harrison, New York, 10604

    Brian Shaffer, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

    Brian Shaffer, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Brian Shaffer, MD, 646-608-2091

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Brian Shaffer, MD, 646-608-2091, ABMTTrials@mskcc.org

    Mark Geyer, MD, 646-608-3745

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New York, 11553

    Brian Shaffer, MD, 646-608-2091

    Recruiting

Other trials in United States

About this study

Official title: Phase I Study of Cytokine Induced Memory-Like Natural Killer Cells Combined With Atezolizumb in Subjects With Relapsed or Refractory Acute Myelogenous Leukemia

The researchers are doing this study is to find the highest dose of cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with the drug atezolizumab that causes few or mild side effects in people with relapsed/refractory acute myelogenous leukemia (AML). The researchers will also look at whether the treatment combination works against participants' cancer.

Being tested
Cytokine Induced Memory-Like Natural Killer Cells, Atezolizumb, CIML-NK cell therapy
Keywords
Atezolizumab, CIML-NK (Cytokine Induced Memory-Like Natural Killer Cells), 24-356
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cytokine Induced Memory-Like Natural Killer CellsBiological

    Subjects will receive subcutaneous recombinant human IL-2 (rh-IL2) every other day x 6 doses beginning on day 0 via subcutaneous injection.

  • AtezolizumbBiological

    Single dose of Atezolizumab IV over 60 minutes IV.

  • CIML-NK cell therapyBiological

    CIML-NK cell therapy as an intravenous (IV) infusion

Study groups in NCT07011004
Study groupRoleWhat they receive
Cytokine Induced Memory-Like Natural Killer Cells Combined with AtezolizumbExperimentalPre-conditioning chemotherapy will consist of a standard lymphodepleting regimen including fludarabine 25 mg/m2 IV daily x 5 on days -6 to - 2 and cyclophosphamide 50 mg/kg IV x 2 on days -5 and -4 prior to the infusion of the CIML-NK cells. Standard MSKCC supportive care guidelines for infusion of chemotherapy including cyclophosphamide will be employed. On the day of infusion subjects will receive a single dose of atezolizumab IV over 60 minutes IV. Subjects will receive subcutaneous recombinant human IL-2 (rh-IL2) every other day x 6 doses beginning on day 0 via subcutaneous injection.
Receives: Biological: Cytokine Induced Memory-Like Natural Killer Cells; Biological: Atezolizumb; Biological: CIML-NK cell therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum tolerated dose (MTD)

    of the combination of CIML-NK cells with atezolizumab in subjects with r/r-AML. The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.

    Measured: 2 years

Secondary outcomes (1)

  1. The response rate (CR/CRi)

    Disease response assessments will be according to the ELN2022 criteria.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start30 May 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase I dose escalation and expansion study designed to evaluate the safety of cytokine induced, memory-like NK cells (CIML-NK) when combined with atezolizumab in patients with relapsed or refractory acute myelogenous leukemia (AML).
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07011004
Sponsor's protocol ID
24-356
Status last verified
Jun 2026
First submitted
30 May 2025
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cytokine Induced Memory-Like Natural Killer Cells, Atezolizumb and CIML-NK cell therapy in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia, in Relapse, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Shaffer, MD (646-608-2091, ABMTTrials@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07011004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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