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NCT03466320 · ClinicalTrials.gov registry record · Phase 1
DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2
A Phase 1 study of AML and MDS, sponsored by Celyad Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 7
- Study locations
NCT03466320: Completed Phase 1 study of AML and MDS, sponsored by Celyad Oncology.
NCT03466320 is a Phase 1 study of AML and MDS that has completed, run by Celyad Oncology. The registered enrollment target is 21 participants, below the 133-participant average among 29 other AML trials with a reported enrollment target (84% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03466320, a Phase 1 study of AML and MDS, has completed, sponsored by Celyad Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 7
- Study locations
Study Summary
This open-label Phase I study aims at assessing primarily the safety of the NKR-2 treatment administered after a non-myeloablative preconditioning regimen in r/r AML/MDS patients. This Phase I study will contain two different sequential segments. The first segment will determine the recommended investigational treatment option (schedule of preconditioning and NKR-2 dose) and the second segment will expand to a larger number of r/r AML/MDS patients.
Primary Outcome
Dose-limiting toxicity refers to a specific adverse event that is experienced during treatment and until 3 weeks after first NKR-2 dose administration, is new and at least possibly related to NKR-2 study treatment administered following a preconditioning regimen
Interventions
- BIOLOGICAL NKR-2
Study Locations (7)
Other
- Universitair Ziekenhuis Antwerpen - Antwerp
- Institute Jules Bordet - Brussels
- UZ Gent - Ghent
Colorado
- University of Colorado - Aurora
Florida
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc., - Tampa
Georgia
- Emory University - Atlanta
New York
- New York School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 1 |
What the finished NCT03466320 record still lists
NCT03466320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 29 other AML trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with AML appearing as the primary indexed condition, and to 1 intervention - of which NKR-2 is the first listed.
NCT03466320 lists 7 locations in 5 states (Other, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT03466320 about?
NCT03466320 is a clinical study titled "DEPLETHINK - LymphoDEPLEtion and THerapeutic Immunotherapy With NKR-2". This open-label Phase I study aims at assessing primarily the safety of the NKR-2 treatment administered after a non-myeloablative preconditioning regimen in r/r AML/MDS patients. This Phase I study will contain two different sequential segments. The first segment will determine the recommended inv...
What is the current status of trial NCT03466320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-09-18. Estimated completion is 2021-02-01.
What conditions does trial NCT03466320 study?
This clinical trial studies the following conditions: AML, MDS.
What interventions are being tested in trial NCT03466320?
The interventions under investigation include: NKR-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03466320?
This trial is sponsored by Celyad Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03466320 being conducted?
This trial has 7 study locations across Colorado, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03466320's enrollment target sits among peer trials
21 23rd of 29 higher than 6 of 29 other AML trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AML 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.
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