drugset
drugset / Trial / NCT05475925

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

NCT05475925 ↗

Phase 1/2 Recruiting 200 enrolled Dren Bio
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2022-07-13
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dibotatug Monoclonal antibody 1 mg/kg —
Subject Dibotatug Monoclonal antibody 3 mg/kg —
Subject Dibotatug Monoclonal antibody 6 mg/kg —
Subject Dibotatug Monoclonal antibody 10 mg/kg —

Indications

T-cell large granular lymphocyte leukemia aggressive NK-cell leukemia enteropathy-associated T-cell lymphoma extranodal nasal NK/T cell lymphoma hepatosplenic T-cell lymphoma hydroa vacciniforme-like lymphoma monomorphic epitheliotropic intestinal T-cell lymphoma peripheral T-cell lymphoma, not otherwise specified primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma primary cutaneous gamma-delta t-cell lymphoma primary cutaneous peripheral T-cell lymphoma not otherwise specified subcutaneous panniculitis-like T-cell lymphoma systemic Epstein-Barr virus-positive T-cell lymphoproliferative disease of childhood