A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL
NCT03239392 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-05-25
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).
Conditions
- LGL Leukemia
- CTCL
Interventions
- 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
Sponsors & Collaborators
-
Bioniz Therapeutics
lead INDUSTRY
Principal Investigators
-
Jonathan Brammer, MD, PhD · Ohio State University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2020-06-30
- Completion
- 2020-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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