CIML NK Cells With Venetoclax for AML
NCT06152809 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-03-18
Summary
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
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Recurrent
- Leukemia
- Leukemia, Myeloid
Interventions
- BIOLOGICAL
-
Cytokine-Induced Memory-like Natural Killer Cells
Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
- BIOLOGICAL
-
Interleukin-2
Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous (under the skin) injection per protocol.
- DRUG
-
Selective inhibitor of BCL-2 protein, 10, 50, or 100 mg tablets, via orally per standard-of-care.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Evan Chen, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-20
- Primary Completion
- 2026-11-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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