RecruitingPhase 1Phase 2NCT05475925

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

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

Sponsor

Dren Bio

Enrollment

200 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

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

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called DR-01 for people with rare blood cancers — specifically Large Granular Lymphocytic Leukemia (a type of slow-growing leukemia affecting immune cells) or aggressive immune cell lymphomas (cancers of certain white blood cells). **You may be eligible if...** - You are 18 or older - You have been diagnosed with Large Granular Lymphocytic Leukemia (LGLL) and have already tried at least one other treatment - Or you have a cytotoxic lymphoma and have tried at least two prior treatments - Your heart, liver, kidneys, and other organs are functioning adequately - You are willing to use effective birth control during the study and for 12 months after **You may NOT be eligible if...** - You have an active serious infection - You have cancer that has spread to the brain - You have HIV, active Hepatitis B, or untreated Hepatitis C - You have significant heart disease - You have had a stem cell transplant very recently (within 40–90 days) - You are currently taking high-dose steroids or other immune-suppressing drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDR-01

DR-01 is a non-fucosylated, human immunoglobulin G1 (IgG1) monoclonal antibody.

Locations(37)

Dren Investigational Site

Birmingham, Alabama, United States

Dren Investigational Site

Duarte, California, United States

Dren Investigational Site

Irvine, California, United States

Dren Investigational Site

Redwood City, California, United States

Dren Investigational Site

New Haven, Connecticut, United States

Dren Investigational Site

Tampa, Florida, United States

Dren Investigational Site

Boston, Massachusetts, United States

Dren Investigational Site 1

New York, New York, United States

Dren Investigational Site 2

New York, New York, United States

Dren Investigational Site

Columbus, Ohio, United States

Dren Investigational Site 2

Pittsburgh, Pennsylvania, United States

Dren Investigational Site

Houston, Texas, United States

Dren Investigational Site

Charlottesville, Virginia, United States

Dren Investigational Site

Fairfax, Virginia, United States

Dren Investigational Site

Seattle, Washington, United States

Dren Investigational Site

Clayton, Victoria, Australia

Dren Investigational Site

Richmond, Victoria, Australia

Dren Investigational Site

Nedlands, Washington, Australia

Dren Investigational Site

Pierre-Bénite, France

Dren Investigational Site

Rennes, France

Dren Investigational Site

Toulouse, France

Dren Investigational Site

Berlin, Germany

Dren Investigational Site

Cologne, Germany

Dren Investigational Site

Leipzig, Germany

Dren Investigational Site 1

Hong Kong, Hong Kong, Hong Kong

Dren Investigational Site 2

Hong Kong, Hong Kong

Dren Investigational Site

Bologna, Italy

Dren Investigational Site 1

Busan, South Korea

Dren Investigational Site 2

Busan, South Korea

Dren Investigational Site

Goyang-si, South Korea

Dren Investigational Site 1

Seoul, South Korea

Dren Investigational Site 2

Seoul, South Korea

Dren Investigational Site 3

Seoul, South Korea

Dren Investigational Site

Barcelona, Spain

Dren Investigational Site

Salamanca, Spain

Dren Investigational Site

Tainan, Taiwan

Dren Investigational Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05475925