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NCT06138587 · ClinicalTrials.gov registry record · Phase 1
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
A Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06138587: Recruiting Phase 1 study of Acute Myeloid Leukemia and Leukemia, sponsored by Dana-Farber Cancer Institute.
NCT06138587 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 15 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06138587, 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
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: * CIML NK cells intravenous infusion (cellular therapy) * Subcutaneous Interleukin-2 (recombinant, human glycoprotein)
Primary Outcome
All DLT was defined as an adverse event (AE) that is related to the CIML NK cell infusion combined with IL-2 in adult patients undergoing RIC HLA-matched related or haploidentical donor stem cell transplantation using PTCY-based GVHD prophylaxis. Toxicities are to be assessed according to the CTCAEv5 (Appendix C). Management and dose modifications associated with the above adverse events are outlined in protocol 6.
Conditions Studied
Interventions
- BIOLOGICAL Interleukin-2
- BIOLOGICAL Cytokine Induced Memory-like Natural Killer Cells
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-01-24 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 1 |
What NCT06138587 shows while recruiting
NCT06138587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower).
The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Interleukin-2 is the first listed.
NCT06138587 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06138587 about?
NCT06138587 is a clinical study titled "Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation". The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN...
What is the current status of trial NCT06138587?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-01-24. Estimated completion is 2027-11-30.
What conditions does trial NCT06138587 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Myeloproliferative Disorders.
What interventions are being tested in trial NCT06138587?
The interventions under investigation include: Interleukin-2 (BIOLOGICAL), Cytokine Induced Memory-like Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06138587?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06138587 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 NCT06138587's enrollment target sits among peer trials
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