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

NCT07011004 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-356
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief 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). The researchers will also look at whether the treatment combination works against participants' cancer.

Conditions

Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia, in Relapse

Keywords

Atezolizumab; CIML-NK (Cytokine Induced Memory-Like Natural Killer Cells); 24-356

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (1)

• The response rate (CR/CRi)

  2 years

Study Arms (1)

Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumb

EXPERIMENTAL

Pre-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.

Biological: Cytokine Induced Memory-Like Natural Killer Cells; Biological: Atezolizumb; Biological: CIML-NK cell therapy

Interventions

Atezolizumb BIOLOGICAL

Single dose of Atezolizumab IV over 60 minutes IV.

Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumb

CIML-NK cell therapy BIOLOGICAL

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

Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumb

Cytokine Induced Memory-Like Natural Killer Cells BIOLOGICAL

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

Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumb

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Brian Shaffer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Shaffer, MD

CONTACT

646-608-2091; ABMTTrials@mskcc.org

Mark Geyer, MD

CONTACT

646-608-3745

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)