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NCT05475925 · ClinicalTrials.gov registry record · Phase 1
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
A Phase 1 study of Hepatosplenic T-cell Lymphoma and Enteropathy-Associated T-Cell Lymphoma, sponsored by Dren Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT05475925 is a Phase 1 study of Hepatosplenic T-cell Lymphoma and Enteropathy-Associated T-Cell Lymphoma that is actively recruiting participants, run by Dren Bio. The registered enrollment target is 69 participants, below the 89-participant average among 12 other Hepatosplenic T-cell Lymphoma trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT05475925, a Phase 1 study of Hepatosplenic T-cell Lymphoma and Enteropathy-Associated T-Cell Lymphoma, is actively recruiting participants, sponsored by Dren Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
Conditions Studied
Interventions
- DRUG DR-01
Study Locations (20)
California
- Dren Investigational Site - Duarte
- Dren Investigational Site - Irvine
- Dren Investigational Site - Redwood City
New York
- Dren Investigational Site 1 - New York
- Dren Investigational Site 2 - New York
Virginia
- Dren Investigational Site - Charlottesville
- Dren Investigational Site - Fairfax
Victoria
- Dren Investigational Site - Clayton
- Dren Investigational Site - Richmond
Other
- Dren Investigational Site - Pierre-Bénite
- Dren Investigational Site - Rennes
Alabama
- Dren Investigational Site - Birmingham
Connecticut
- Dren Investigational Site - New Haven
Florida
- Dren Investigational Site - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05475925
The ClinicalTrials.gov registry entry for NCT05475925 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 89-participant average among 12 other Hepatosplenic T-cell Lymphoma trials with a reported enrollment target (22% lower). The listed sponsor is Dren Bio, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Hepatosplenic T-cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which DR-01 is the first listed.
NCT05475925 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT05475925 about?
NCT05475925 is a clinical study titled "A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas". This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
What is the current status of trial NCT05475925?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2022-07-13. Estimated completion is 2026-12.
What conditions does trial NCT05475925 study?
This clinical trial studies the following conditions: Hepatosplenic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, Aggressive NK-cell Leukemia, Hydroa Vacciniforme-Like Lymphoproliferative Disorder, LGLL - Large Granular Lymphocytic Leukemia.
What interventions are being tested in trial NCT05475925?
The interventions under investigation include: DR-01 (DRUG).
Who is sponsoring clinical trial NCT05475925?
This trial is sponsored by Dren Bio, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05475925 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Hepatosplenic T-cell Lymphoma
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Enteropathy-Associated T-Cell Lymphoma
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