Actively Recruiting
A Phase 1 Study of Cytokine-Induced Memory-like Natural Killer Cells Combined With Venetoclax and IL-2 as Consolidation Therapy in Acute Myeloid Leukemia
Led by Dana-Farber Cancer Institute · Updated on 2026-03-18
10
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination treatment for adults with Acute Myeloid Leukemia (AML). This phase 1 trial tests the safety and explores the effects of infusing cytokine-induced memory-like natural killer (CIML NK) cells along with low-dose Interleukin-2 (IL-2) and the approved drug venetoclax. The study is sponsored by the Dana-Farber Cancer Institute and funded by the Leukemia and Lymphoma Society. It is the first time CIML NK cells are combined with venetoclax in humans. Participants receive a lymphodepleting chemotherapy regimen with fludarabine and cyclophosphamide before the CIML NK cell infusion. The treatment includes a single infusion of CIML NK cells, subcutaneous IL-2 injections every other day for up to five doses, and daily oral venetoclax for about two weeks. Hospitalization for 3 to 4 weeks is expected during the CIML NK infusion. Dosage levels will be adjusted based on observed toxicities, and follow-up visits occur up to one year after treatment. During the study, participants undergo screening, bone marrow biopsies, blood tests, electrocardiograms, and echocardiograms to monitor health and treatment effects. Researchers measure dose-limiting toxicities, maximum tolerated dose, leukemia remission rates, and survival outcomes. Follow-ups happen at days 42, 60, 100, and months 6, 9, and 12 to assess safety and effectiveness. Participants' organ functions and infection status are carefully monitored throughout the trial.
CONDITIONS
Brief Title
CIML NK Cells With Venetoclax for AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML)
- Age 18 years or older
- Currently treated with hypomethylating agents (azacitidine or decitabine) plus venetoclax and have received at least one cycle
- May have received prior chemotherapy or stem cell transplant if done more than 6 months ago without ongoing immunosuppressive therapy
- Presence of molecular risk factors for relapse as defined by specific karyotype or mutations
- ECOG performance status 0 to 2
- Adequate organ function including bilirubin, liver enzymes, kidney function, oxygen saturation, and heart function
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during the study
- Ability to understand and sign informed consent
- Ability to swallow pills
- No laboratory evidence of ongoing hemolysis
You will not qualify if you...
- Prior allogeneic stem cell transplant, organ transplant, donor lymphocyte infusion, CAR-T cell, or NK cell therapy
- Persistent grade greater than 1 non-hematologic toxicity from prior therapy except mild alopecia or sensory neuropathy
- History of autoimmune diseases requiring significant immunosuppressive therapy, except Hashimoto's thyroiditis
- Pregnant or breastfeeding women
- HIV-positive status
- Active uncontrolled hepatitis B or C infection
- History of other malignancies unless in remission for at least 2 years or certain treated skin or prostate cancers
- Severe allergic reactions to IL-2 or study agents
- Receiving other investigational agents for AML
- Uncontrolled illnesses including serious infections or heart conditions
- Prior history of grade 2 or higher hemolytic anemia
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.
2 screening visits including bone marrow biopsies and blood tests
Duration - Approximately 3 to 4 weeks
Participants receive lymphodepleting chemotherapy, followed by a hospital stay for infusion of CIML NK cells combined with IL-2 injections every other day and daily venetoclax tablets as consolidation therapy for AML.
Hospitalization for up to 3 to 4 weeks with daily treatments and injections during this period
Duration - Up to 1 year after start of therapy
Participants are monitored through follow-up visits to assess safety, leukemia-free survival, and overall survival.
Follow-up visits on Days 42, 60, 100 and at months 6, 9, and 12
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
E
Evan Chen, MD
R
Rizwan Romee, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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