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Clinical Trial 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).


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03239392
Study type Interventional
Source Bioniz Therapeutics
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 1, 2018
Completion date June 30, 2020

See also
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