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NCT03081780 · ClinicalTrials.gov registry record · Phase 1
Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03081780: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT03081780 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03081780, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia (AML). FATE-NK100 is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype. The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a related donor (HLA-haploidentical or better but not fully HLA-matched) that is seropositive for cytomegalovirus (CMV+), and enriched for adaptive NK cells by depletion of CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells followed by ex-vivo culture expansion.
Primary Outcome
Maximum FATE-NK100 dose which could be given to 3 participants such that not more than 1 participant experienced a DLT.
Interventions
- BIOLOGICAL FATE-NK100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2020-12-01 |
| Phase | Phase 1 |
What the finished NCT03081780 record still lists
NCT03081780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which FATE-NK100 is the first listed.
NCT03081780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03081780 about?
NCT03081780 is a clinical study titled "Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML". This is a Phase I open-label dose escalation study of a single infusion of FATE-NK100 and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy (CY/FLU) in subjects with refractory or relapsed acute myelogenous leukemia (AML). FATE-NK100 is a natural kil...
What is the current status of trial NCT03081780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-04-27. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03081780?
The interventions under investigation include: FATE-NK100 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03081780?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03081780's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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