Actively Recruiting
A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09
18
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 through 70 years old
- Histologically confirmed acute myeloid leukemia refractory to at least two prior induction therapies or relapsed within 6 months of initial remission
- Patients with FLT3 mutations must have received at least one FLT3 inhibitor
- Patients with NPM1 or MLL rearrangements must be refractory to revumenib
- Patients with IDH1 or IDH2 mutations must be refractory to at least one inhibitor of IDH1 or IDH2
- Karnofsky performance status of 70% or higher
- Adequate cardiac function with systolic left ventricular ejection fraction 50% or higher and no severe congestive heart failure
- Adequate pulmonary function with resting oxygen saturation 92% or higher on room air
- Serum bilirubin 5 mg/dL or less
- AST and ALT 2.5 times upper limit of normal or less, unless disease-related
- Creatinine clearance greater than 50 mL/min
- No systemic immune suppression for at least 4 weeks prior to therapy
- Availability of a haplotype mismatched related cell donor who meets FACT guidelines
- Negative HIV test at screening
- Negative hepatitis B surface antigen or controlled hepatitis B infection
- Negative hepatitis C antibody test or negative RNA test if antibody positive
- Stable anticoagulant regimen if receiving therapeutic anticoagulation
- Bridging therapy with hydrea allowed but must be tapered off before NK infusion
- Discontinuation of experimental biological treatments for at least 5 half-lives prior to study therapy
- More than 5 half-lives from other cytotoxic or targeted therapies
- For women of childbearing potential: agreement to abstain or use effective contraception during and for 5 months after treatment, and to refrain from egg donation
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplantation
- Active or uncontrolled central nervous system leukemia
- Need for systemic immunosuppression for any reason
- Significant cardiovascular disease including congestive heart failure NYHA class II or higher, recent myocardial infarction or stroke within 6 months, unstable arrhythmia or angina
- Isolated extramedullary disease without bone marrow involvement
- Pregnancy, breastfeeding, or intent to become pregnant during treatment or within 5 months after last dose
- Severe or uncontrolled infection
- Recent therapeutic oral or IV antibiotics within 2 weeks prior to treatment
- History of pulmonary fibrosis, pneumonitis, or active pneumonitis on screening CT scan
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune diseases or immune deficiency except well-controlled hypothyroidism, type 1 diabetes on insulin, or limited dermatologic autoimmune conditions
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Not meeting age or organ function criteria
- Severe allergic reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or atezolizumab components
- Donors not eligible for apheresis or with reactive HLA antibodies against recipient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
B
Brian Shaffer, MD
CONTACT
M
Mark Geyer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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