Immune cell combo targets stubborn leukemia in early trial
NCT ID NCT07011004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment for adults with acute myeloid leukemia (AML) that has come back or not responded to standard therapy. The treatment combines specially trained natural killer (NK) immune cells with a drug called atezolizumab. The main goal is to find a safe dose and see if the combination can shrink the cancer. About 18 participants will be enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. * 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. Exclusion Criteria: * 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. 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
Contact Email: •••••@•••••
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Memorial Sloan Kettering Monmouth (Limited protocol activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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