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NCT04594642 · ClinicalTrials.gov registry record · Phase 1
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
A Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 317
- Enrollment target
- 20
- Study locations
NCT04594642: Recruiting Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma, sponsored by AstraZeneca.
NCT04594642 is a Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 317 participants, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04594642, a Phase 1 study of Diffuse Large B Cell Lymphoma and Follicular Lymphoma, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 317 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).
Primary Outcome
A DLT is defined as a TEAE that is not unequivocally due to the subject's underlying malignancy or other extraneous cause. DLT evaluable subjects are defined as those subjects who receive either the target dose of AZD0486 or priming dose(s) in any step-up dose schedule and are assessed for toxicities for the 28-day evaluation period. The NCI-CTCAE version 5.0 will be used (except for CRS and NT). A DLT will be evaluated as Non-hematologic, Hematologic, Cytokine Release Syndrome (CRS), or neurot
Conditions Studied
Interventions
- DRUG AZD0486 IV
Study Locations (20)
Other
- Research Site - Bedford Park
- Research Site - Heidelberg
- Research Site - Hobart
- Research Site - Melbourne
- Research Site - Chūōku
- Research Site - Kōtoku
- Research Site - Nagoya
- Research Site - Yamagata
- Research Site - Seoul
- Research Site - Seoul
Texas
- Research Site - Austin
- Research Site - Houston
Florida
- Research Site - Tampa
Kentucky
- Research Site - Louisville
New Jersey
- Research Site - New Brunswick
North Carolina
- Research Site - Charlotte
Ohio
- Research Site - Columbus
Oregon
- Research Site - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2028-04-19 |
| Phase | Phase 1 |
What NCT04594642 shows while recruiting
NCT04594642 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (47% higher).
The record links to 4 conditions, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which AZD0486 IV is the first listed.
NCT04594642 names 20 study sites across 10 states, led by Other, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT04594642 about?
NCT04594642 is a clinical study titled "A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma". This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).
What is the current status of trial NCT04594642?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 317 participants. The study started on 2021-03-02. Estimated completion is 2028-04-19.
What conditions does trial NCT04594642 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma, Follicular Lymphoma, High Grade B-Cell Lymphoma, B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT04594642?
The interventions under investigation include: AZD0486 IV (DRUG).
Who is sponsoring clinical trial NCT04594642?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04594642 being conducted?
This trial has 20 study locations across Florida, Kentucky, New Jersey, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04594642's enrollment target sits among peer trials
317 17th of 114 higher than 98 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma 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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