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NCT02384954 · ClinicalTrials.gov registry record · Phase 1
QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab
A Phase 1 study, sponsored by Altor BioScience.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02384954: Clinical Trial Phase 1 study, sponsored by Altor BioScience.
NCT02384954 is a Phase 1 study that was terminated before completion, run by Altor BioScience. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02384954, a Phase 1 study, was terminated before completion, sponsored by Altor BioScience.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab.
Primary Outcome
Maximum Tolerated Dose level (MTD) is defined as a dose level at which \<2 out of 6 patients experienced Dose Limiting Toxicity (DLT) and that is one level below a dose that was not tolerated. Minimal Efficacious Dose (MED) is defined as a dose level which produces an Absolute Lymphocyte Count (ALC) ≥25,000/μL sustained for 14 days or a total WBC ≥35,000/μL sustained for 14 days among 2/3 or 4/6 of patients. The elevated ALC cannot be attributed to circulating lymphoma cells. Dose levels for N-8
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL N-803
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-04-17 |
| Est. Completion | 2020-12-13 |
| Phase | Phase 1 |
Why NCT02384954 stopped before completion
NCT02384954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT02384954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02384954 about?
NCT02384954 is a clinical study titled "QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab". This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab.
What is the current status of trial NCT02384954?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-04-17. Estimated completion is 2020-12-13.
What interventions are being tested in trial NCT02384954?
The interventions under investigation include: Rituximab (BIOLOGICAL), N-803 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02384954?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02384954's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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