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NCT06152809 · ClinicalTrials.gov registry record · Phase 1
CIML NK Cells With Venetoclax for AML
A Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT06152809: Recruiting Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Dana-Farber Cancer Institute.
NCT06152809 is a Phase 1 study of Acute Myeloid Leukemia and Leukemia that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 10 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06152809, a Phase 1 study of Acute Myeloid Leukemia and Leukemia, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study 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)
Primary Outcome
A DLT is defined as an adverse event (AE) that is related to the CIML NK cell infusion with venetoclax as consolidation therapy. Toxicities are to be assessed according to the CTCAEv5.
Conditions Studied
Interventions
- DRUG Venetoclax
- BIOLOGICAL Interleukin-2
- BIOLOGICAL Cytokine-Induced Memory-like Natural Killer Cells
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-02-20 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What NCT06152809 shows while recruiting
NCT06152809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT06152809 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06152809 about?
NCT06152809 is a clinical study titled "CIML NK Cells With Venetoclax for AML". 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...
What is the current status of trial NCT06152809?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2024-02-20. Estimated completion is 2027-11-30.
What conditions does trial NCT06152809 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, Leukemia, Myeloid, Acute Myeloid Leukemia Recurrent.
What interventions are being tested in trial NCT06152809?
The interventions under investigation include: Venetoclax (DRUG), Interleukin-2 (BIOLOGICAL), Cytokine-Induced Memory-like Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06152809?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06152809 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06152809's enrollment target sits among peer trials
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