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NCT03912831 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers
A Phase 1 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03912831: Clinical Trial Phase 1 study, sponsored by Gilead Sciences.
NCT03912831 is a Phase 1 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03912831, a Phase 1 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human leukocyte antigen (HLA)-A\*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+ cancers.
Primary Outcome
A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to ≤Grade 2 events within 48 hours, ≥Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Interleukin-2
- DRUG KITE-439
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2022-02-18 |
| Phase | Phase 1 |
Why NCT03912831 stopped before completion
NCT03912831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03912831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03912831 about?
NCT03912831 is a clinical study titled "Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers". This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human leukocyte antigen (HLA)-A\*02:01+ a...
What is the current status of trial NCT03912831?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-04-30. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT03912831?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Interleukin-2 (DRUG), KITE-439 (DRUG).
Who is sponsoring clinical trial NCT03912831?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03912831's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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