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

NCT05475925 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-17

No results posted yet for this 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

  • 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)

Interventions

DRUG

DR-01

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

Sponsors & Collaborators

  • Dren Bio

    lead INDUSTRY

Principal Investigators

  • Wan-Jen Hong, MD · Dren Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Hong Kong
  • Italy
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475925 on ClinicalTrials.gov