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RecruitingPriority 2 · High priorityNCT05475925

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

ClinicalTrials.gov

Plain-language summary

This trial is testing DR-01 for patients with enteropathy-associated T-cell lymphoma, extranodal NK/T-cell lymphoma, hepatosplenic T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), or subcutaneous panniculitis-like T-cell lymphoma at various stages of their disease. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 15 locations in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 18 Years or older
  • See full trial listing for complete eligibility

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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

  • DR-01

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

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What is PTCL-NOS?

Plain-language overview of PTCL-NOS plus all curated trials for this subtype.

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TrialCompass — Clinical Trial Summary

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

NCT05475925

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: High

Plain-language summary

This trial is testing DR-01 for patients with enteropathy-associated T-cell lymphoma, extranodal NK/T-cell lymphoma, hepatosplenic T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), or subcutaneous panniculitis-like T-cell lymphoma at various stages of their disease. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. Patients are randomly assigned to different treatment groups. This trial is available at 15 locations in the United States. The trial is currently recruiting patients.

Who can join

  • Age 18 Years or older
  • See full trial listing for complete eligibility

What's being tested

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

Drugs / treatments: DR-01

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 200 patients

Primary endpoint: Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.; Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.; 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.; 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.

Ages: 18 Years to —

Start date: 2022-07-13 | Est. completion: 2026-12

Locations

15 US sites · 37 total

Alabama, California, Connecticut, Florida, Massachusetts, New York, Ohio, Pennsylvania, Texas, Virginia, Washington

Contact

Dren Central Contact | DR-01-ONC-001_inquiries@drenbio.com | 415-737-5277

Sponsor: Dren Bio (INDUSTRY)

Tags

EATL · ENKTL · HSTCL · MEITL · PTCL-NOS · SPTCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05475925

Prepared using TrialCompass (trialcompass.com) on August 3, 2026. For informational purposes only. Always discuss with your healthcare team.