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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 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 6 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03081780
The ClinicalTrials.gov registry entry for NCT03081780 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FATE-NK100 is the first listed.
NCT03081780 reports 0 study locations.
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.
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