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NCT03704298 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03704298: Clinical Trial Phase 1 study, sponsored by Kite, A Gilead Company.
NCT03704298 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
NCT03704298, 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 primary objectives of this study are: Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utomilumab as measured by complete response rate in participants with refractory large B-cell lymphoma
Primary Outcome
DLTs are study drug-related events with onset within first 28 days following infusion of axicabtagene ciloleucel or utomilumab: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia or B-cell aplasia) * All study drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1 within 2 weeks or baseline within 4 weeks, fever of any grade, immedi
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
- BIOLOGICAL Utomilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 1 |
Why NCT03704298 stopped before completion
NCT03704298 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT03704298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03704298 about?
NCT03704298 is a clinical study titled "Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma". The primary objectives of this study are: Phase 1: To evaluate the safety of axicabtagene ciloleucel in combination with utomilumab and to identify the most appropriate dose and timing of utomilumab to carry forward into Phase 2 Phase 2: To evaluate the efficacy of axicabtagene ciloleucel and utom...
What is the current status of trial NCT03704298?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-11-20. Estimated completion is 2022-12-15.
What interventions are being tested in trial NCT03704298?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL), Utomilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03704298?
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 NCT03704298'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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