NCT05475925

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dren Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2022-07-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-07-27
• Last updated: 2026-04-17

Locations

37 sites across 9 countries: United States, Australia, France, Germany, Hong Kong, Italy, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study