Actively Recruiting
Phase I Study of Cytokine Induced Memory-Like Natural Killer Cells Combined with Atezolizumab in Relapsed or Refractory Acute Myelogenous Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09
18
Participants Needed
7
Research Sites
N/A
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
Researchers are studying the highest safe dose of cytokine-induced memory-like (CIML) natural killer (NK) cells combined with the drug atezolizumab in people with relapsed or refractory acute myelogenous leukemia (AML). This phase 1 trial aims to find a dose that causes few or mild side effects and to evaluate whether this treatment combination affects the participants' cancer. Participants will receive pre-conditioning chemotherapy with fludarabine and cyclophosphamide before an intravenous infusion of CIML-NK cells. On the day of infusion, they will be given a single intravenous dose of atezolizumab over 60 minutes. Following this, subcutaneous injections of recombinant human IL-2 will be administered every other day for six doses starting on the infusion day. During the study, participants will be closely monitored for side effects and response to treatment over a two-year period. Researchers will assess the maximum tolerated dose and response rates, including complete remission. Evaluations include regular clinical assessments and laboratory tests to monitor cancer status and safety. The study lasts up to two years for outcome measurement and safety follow-up.
CONDITIONS
Brief 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
- Diagnosed with acute myeloid leukemia that is refractory to at least two prior induction therapies or relapsed within 6 months of initial remission
- Patients with certain mutations must have received or be refractory to specific inhibitors as detailed in the protocol
- Must have a suitable haplotype mismatched related donor for cell donation
- Karnofsky performance status of 70% or higher
- Adequate heart function with left ventricular ejection fraction of 50% or greater and no severe heart failure
- Adequate lung function with resting oxygen saturation of 92% or more on room air
- Liver function within specified limits (bilirubin ≤ 5 mg/dL, AST and ALT ≤ 2.5x upper limit of normal unless disease related)
- Kidney function with creatinine clearance over 50 mL/min
- Free from systemic immune suppression for at least 4 weeks before therapy
- Women of childbearing potential must agree to abstain or use contraception during treatment and for 5 months after final dose
- Negative HIV and hepatitis B and C tests as specified
- Stable anticoagulant regimen if applicable
- Timing requirements for prior therapies including washout periods
You will not qualify if you...
- Previous allogeneic hematopoietic cell transplantation
- Active or uncontrolled central nervous system leukemia
- Need for systemic immunosuppression
- Significant cardiovascular disease including recent heart attack, stroke, unstable arrhythmia, or unstable angina
- Isolated extramedullary disease without bone marrow involvement
- Pregnancy, breastfeeding, or intent to become pregnant during treatment or 5 months after final dose
- Severe or uncontrolled infection
- Recent therapeutic antibiotic treatment (within 2 weeks), excluding prophylaxis
- History or evidence of certain lung diseases or active pneumonitis
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune or immune deficiency diseases except specific controlled conditions
- Recurrent fluid buildup requiring frequent drainage procedures
- Severe allergies to related antibodies or atezolizumab components
- Donors with HLA genotypes reactive against recipient antibodies or ineligible for apheresis according to guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive pre-conditioning chemotherapy followed by an infusion of CIML-NK cell therapy combined with a single dose of atezolizumab and subcutaneous IL-2 injections.
Multiple visits including chemotherapy infusions and IL-2 injections every other day for 6 doses
Duration - Up to 2 years
Participants are monitored for safety and response following treatment.
Regular follow-up visits over 2 years
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
M
Mark Geyer, MD
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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