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A Study of DR-01 for Large Granular Lymphocytic Leukemia and Cytotoxic Lymphomas

This study is testing a new medication called DR-01 for adults with certain types of blood cancers, including Large Granular Lymphocytic Leukemia (LGLL) and various cytotoxic lymphomas (cancers affecting specific immune cells). DR-01 is a type of antibody designed to target cancer cells. The main goals are to understand how safe DR-01 is, what side effects it might cause, and how well your body handles it. Researchers will also look for signs that DR-01 is helping to fight the cancer. This is a first-in-human study, meaning it's one of the first times DR-01 is being given to people. The study plans to enroll up to 200 participants.

Study design
This is a multicenter, first-in-human study to evaluate DR-01. It is an interventional study, but the specific phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured for up to 25 months. The pharmacologically optimized dose will be determined within 6 months.

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NCT05475925

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dren Bio
~200 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:DR-01

At a glance

Recruiting sites
36 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Measured over Up to 25 months
+3 more outcomes measured

Conditions

LGLL - Large Granular Lymphocytic Leukemia
Primary Cutaneous Gamma-Delta T-Cell Lymphoma
Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma
Hepatosplenic T-cell Lymphoma
Subcutaneous Panniculitis-Like T-Cell Lymphoma
Aggressive NK Cell Leukemia
Systemic EBV1 T-cell Lymphoma, if CD8 Positive
Hydroa Vacciniforme-Like Lymphoproliferative Disorder
Extranodal NK/T Cell Lymphoma, Nasal Type
Enteropathy-Associated T-Cell Lymphoma
Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)

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Where it's being run

37 sites across 19 states
South Korea6
California3
France3
Germany3
New York2
Virginia2
Washington2
Victoria2

Study leadership

  • Wan-Jen Hong, MD · STUDY_DIRECTOR · Dren Bio

Who to contact

Dren Central Contact
[email protected]
415-737-5277
Email the study team

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What this trial measures

  • Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.Up to 25 months
  • Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.During First 28 days (Cycle 1)
  • Part A: To determine potential pharmacologically optimized dose/regimen for DR-01 in LGL leukemia and cytotoxic lymphoma populations as determined using an integrated assessment of efficacy, safety, PK/PD, and exposure-response relationships.Up to 6 months
  • Part B: Overall Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR) based on disease-specific response criteria.Up to 24 months