Phase 12 Study of DR-01 to Test Safety and Effectiveness in Adults with Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

What this Trial Is About

Researchers are evaluating DR-01, a non-fucosylated human immunoglobulin G1 monoclonal antibody, in adult patients with large granular lymphocytic leukemia or various cytotoxic lymphomas. This first-in-human, multicenter Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in these patient populations. The study is sponsored by Dren Bio and involves sequential dose escalation and expansion cohorts to find the optimal treatment regimen. Participants will receive DR-01 at different starting doses ranging from 0.3 mgkg to 10 mgkg, following one of three dosing schedules during the first month bi-weekly dosing, dosing on days 1, 8, 15, and 29, or dosing on days 1-5, 15, and 29. After the first month, dosing continues monthly with doses adjusted up to 10 mgkg for up to 25 cycles. Dose escalation and de-escalation cohorts are included, and optimized dosing regimens are evaluated separately for leukemia and lymphoma subjects in expansion phases. Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and overall response rates using disease-specific criteria. Safety and pharmacological assessments will occur up to 25 months, with special focus on the first 28 days for dose-limiting toxicities and up to 6 months for dose optimization. Participants will undergo regular evaluations including clinical assessments and tissue biopsies when applicable. The study aims to determine the best dosage while closely monitoring safety and treatment effects over two years.

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