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NCT04789408 · ClinicalTrials.gov registry record · Phase 1
Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04789408: Clinical Trial Phase 1 study, sponsored by Kite, A Gilead Company.
NCT04789408 is a Phase 1 study that was terminated before completion, run by Kite, A Gilead Company. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789408, a Phase 1 study, was terminated before completion, sponsored by Kite, A Gilead Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
Primary Outcome
DLTs defined as KITE-222-related events with an onset within the first 28 days after the KITE-222 infusion:Grade(GR) 5 event,GR 4 cytokine release syndrome(CRS) or GR 3 CRS not improving to ≤ GR 2 by 72 hours,≥GR 3 cardiac and/or pulmonary event(Exceptions:related to CRS and improve to ≤GR 2 by 72 hours, managed by noninvasive care \& resolves to baseline by Day28),GR 4 immune-effector cell-associated neurotoxicity syndrome(ICANS) or other GR 4 adverse events(AEs)associated to neurologic events,
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL KITE-222
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2024-05-18 |
| Phase | Phase 1 |
Why NCT04789408 stopped before completion
NCT04789408 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04789408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04789408 about?
NCT04789408 is a clinical study titled "Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia". The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
What is the current status of trial NCT04789408?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2021-07-19. Estimated completion is 2024-05-18.
What interventions are being tested in trial NCT04789408?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), KITE-222 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04789408?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04789408's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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