A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Public ClinicalTrials.gov record NCT05475925. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Study identification
- NCT ID
- NCT05475925
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Dren Bio
- Industry
- Enrollment
- 200 participants
Conditions and interventions
Conditions
- Aggressive NK Cell Leukemia
- Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
- Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
- Enteropathy-Associated T-Cell Lymphoma
- Extranodal NK/T Cell Lymphoma, Nasal Type
- Hepatosplenic T-cell Lymphoma
- Hydroa Vacciniforme-Like Lymphoproliferative Disorder
- LGLL - Large Granular Lymphocytic Leukemia
- Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
- Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma
- Primary Cutaneous Gamma-Delta T-Cell Lymphoma
- Subcutaneous Panniculitis-Like T-Cell Lymphoma
- Systemic EBV1 T-cell Lymphoma, if CD8 Positive
Interventions
- DR-01 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2022
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Apr 16, 2026
2022 – 2026
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dren Investigational Site | Birmingham | Alabama | 35233 | Recruiting |
| Dren Investigational Site | Duarte | California | 91010 | Recruiting |
| Dren Investigational Site | Irvine | California | 92612 | Recruiting |
| Dren Investigational Site | Redwood City | California | 94063 | Recruiting |
| Dren Investigational Site | New Haven | Connecticut | 06519 | Recruiting |
| Dren Investigational Site | Tampa | Florida | 33612 | Recruiting |
| Dren Investigational Site | Boston | Massachusetts | 02114 | Recruiting |
| Dren Investigational Site 1 | New York | New York | 10021 | Recruiting |
| Dren Investigational Site 2 | New York | New York | 10032 | Not yet recruiting |
| Dren Investigational Site | Columbus | Ohio | 43210 | Recruiting |
| Dren Investigational Site 2 | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Dren Investigational Site | Houston | Texas | 77030 | Recruiting |
| Dren Investigational Site | Charlottesville | Virginia | 22903 | Recruiting |
| Dren Investigational Site | Fairfax | Virginia | 22031 | Recruiting |
| Dren Investigational Site | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05475925, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2026 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05475925 live on ClinicalTrials.gov.