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Brief Title: A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL
Official Title: A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma
Study ID: NCT03239392
Brief 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
The James Cancer Center, Ohio State University, Columbus, Ohio, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Name: Jonathan Brammer, MD, PhD
Affiliation: Ohio State University
Role: PRINCIPAL_INVESTIGATOR