Actively Recruiting
CIML NK Cells With Venetoclax for AML
Led by Dana-Farber Cancer Institute · Updated on 2026-03-18
10
Participants Needed
2
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: * Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion * CIML NK (a cellular therapy) * IL-2 (a recombinant, human glycoprotein) * Venetoclax (a selective inhibitor of BCL-2 protein)
CONDITIONS
Official 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 azacitidine or decitabine plus venetoclax therapy and received at least one cycle
- May have had prior chemotherapy or stem cell transplant over 6 months ago without ongoing immunosuppressive therapy
- Presence of molecular risk factors for relapse as defined by specific genetic abnormalities or mutations
- ECOG performance status of 2 or less
- Adequate organ function including bilirubin, liver enzymes, creatinine clearance, oxygen saturation, and heart function
- Negative pregnancy test for women of childbearing potential
- Agreement to use contraception during study participation and for 4 months after last IL-2 dose
- Cardiac disease status of class 2B or better by NYHA classification
- Ability and willingness to provide 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
- Grade 2 or higher ongoing non-hematologic toxicity from prior therapy except certain mild conditions
- Autoimmune diseases requiring significant immunosuppressive therapy, including inflammatory bowel disease and several others, except Hashimoto's thyroiditis
- Pregnancy or breastfeeding
- HIV infection
- Active uncontrolled hepatitis B or C
- History of other malignancy unless in remission for 2 years or certain low-risk cancers treated within 2 years
- Severe allergic reactions to IL-2 or study agents
- Use of other investigational agents for this condition
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, or psychiatric/social situations limiting compliance
- Prior history of significant hemolytic anemia
- No live vaccines within the last 6 months
- Active infections
- Use of moderate or strong CYP3A inhibitors except specified antifungals with adjusted venetoclax dose
- Presence of donor-specific antibodies above defined level without desensitization
- Significant clinical changes increasing risk of adverse events at treatment timepoints
- Systemic steroid therapy above 10 mg prednisone equivalent on NK cell infusion day
AI-Screening
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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
CONTACT
R
Rizwan Romee, MD
CONTACT
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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