A Study of Natural Killer Cells and Atezolizumab for Relapsed/Refractory AML
This study is looking for the safest and most effective dose of a combination treatment for people with acute myelogenous leukemia (AML) that has come back or not responded to previous treatments. The treatment involves cytokine-induced memory-like (CIML) natural killer (NK) cells, which are a type of immune cell, given along with a drug called atezolizumab. You may be able to join if you are between 18 and 70 years old and have AML that is refractory (not responding) to at least two prior treatments or has relapsed. Researchers will be watching for side effects and how well the treatment works against the cancer. The study plans to enroll 18 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 18 participants. It is designed to find the highest dose of the treatment combination that causes few or mild side effects.
- What's involved
- Participants will receive subcutaneous recombinant human IL-2 every other day for 6 doses, a single intravenous dose of Atezolizumab, and CIML-NK cell therapy as an intravenous infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose will be measured at 2 years, suggesting a follow-up period of at least this duration.
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NCT07011004
A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
Recruiting
PHASE1Ages 18–70InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~18 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Cytokine Induced Memory-Like Natural Killer CellsAtezolizumbCIML-NK cell therapy
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The maximum tolerated dose (MTD)
Measured over 2 years
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Brian Shaffer, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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.
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.
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.
Exclusion
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
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.
What this trial measures
- The maximum tolerated dose (MTD)2 years
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.