NCT03239392

A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bioniz Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).

Detailed description

This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The study has 5 periods: * Screening Period * 4-week Treatment Period * 3-month Treatment Extension Period * Long-term Extension Period (open-ended) * 6-week Follow-up Period Subjects will be screened for eligibility within 30 days of study Day 1 (first dosing day of the 4-Week Treatment Period).

Conditions

• LGL Leukemia
• CTCL

Interventions

Type	Name	Description
DRUG	BNZ132-1-40	Injectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2017-08-04
• Last updated: 2021-05-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study