A Study of Natural Killer Cells in Combination With Atezolizumab in People With Acute Myelogenous Leukemia
Phase I Study of Cytokine Induced Memory-Like Natural Killer Cells Combined With Atezolizumb in Subjects With Relapsed or Refractory Acute Myelogenous Leukemia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests natural killer (NK) cells, a type of immune cell, with the drug atezolizumab. It is for adults ages 18–70 with acute myeloid leukemia (AML), a blood cancer, that came back or did not respond to treatment. Researchers will find the highest cell dose that causes few or mild side effects and check whether the treatment fights the cancer.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have AML confirmed by a tissue test that meets the study’s rules for failed treatment or return of cancer within 6 months of remission.
- Meet prior treatment rules, including treatments aimed at certain gene changes. Approved drugs must have failed or be unlikely to work, in your doctor’s view.
- Be 18–70 years old and able to care for yourself, even if you cannot do normal activities or work.
- Have a related donor who is a partial tissue match and meets cell donation and immune-matching rules.
- Meet heart, lung, liver, and kidney test requirements.
- Have stopped medicines that weaken the immune system for at least 4 weeks. Meet required waiting periods after other cancer treatments.
- Have a negative HIV test and meet hepatitis B and C test rules. If taking blood thinners for treatment, the dose plan must be stable for 2 weeks.
- If able to become pregnant, avoid sex that could cause pregnancy or use highly effective birth control during treatment and for 5 months after the last atezolizumab dose. Do not donate eggs during this time.
Who can't join
- Have had a blood stem cell transplant from another person, or have AML only outside the bone marrow.
- Have active or uncontrolled leukemia in the brain or spinal cord. Past disease there must be absent from spinal fluid tests for at least 4 weeks.
- Need medicines that weaken the immune system, or have certain immune system diseases. Some controlled thyroid disease, type 1 diabetes, and limited skin conditions are allowed.
- Have serious heart or blood vessel disease, including a recent heart attack or stroke, unstable heartbeat, or unstable chest pain.
- Are pregnant, breastfeeding, or planning pregnancy during treatment or within 5 months after the last atezolizumab dose. Those able to become pregnant need a negative blood pregnancy test.
- Have a severe or uncontrolled infection, or have taken oral or IV antibiotics to treat an infection within 2 weeks before treatment. Medicines used to prevent infection are allowed.
- Have certain lung scarring or inflammation, uncontrolled or symptom-causing high calcium, or fluid around the lungs, heart, or belly needing drainage at least monthly.
- Have had a severe allergic reaction to certain antibody or protein medicines, or have a known allergy to atezolizumab ingredients or products made with Chinese hamster ovary cells.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (7)
NJ
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Brian Shaffer, MD · Study contact · 646-608-2091More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited protocol activities) · Middletown, NJ 07748Brian Shaffer, MD · Study contact · 646-608-2091More trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Brian Shaffer, MD · Study contact · 646-608-2091More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) · Commack, NY 11725Brian Shaffer, MD · Study contact · 646-608-2091More trials in Commack
- Memorial Sloan Kettering West Harrison (Limited Protocol Activities) · Harrison, NY 10604Brian Shaffer, MD · Study contact · 646-608-2091More trials in Harrison
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Brian Shaffer, MD · Study contact · 646-608-2091 · ABMTTrials@mskcc.orgMark Geyer, MD · Study contact · 646-608-3745Brian Shaffer, MD · Principal investigatorMore trials in New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) · Rockville Centre, NY 11553Brian Shaffer, MD · Study contact · 646-608-2091More trials in Rockville Centre