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

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ClinicalTrials.gov Identifier: NCT03239392
Recruitment Status : Recruiting
First Posted : August 4, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bioniz Therapeutics

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).

Condition or disease Intervention/treatment Phase
LGL Leukemia CTCL Drug: BNZ132-1-40 Phase 1 Phase 2

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 four periods:

  • Screening Period
  • 4-week Treatment Period
  • 3-month Treatment Extension Period
  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T‑Cell Lymphoma
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 30, 2018


Arm Intervention/treatment
Experimental: BNZ-1
IV PEGylated BNZ132-1-40
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
Other Name: BNZ-1




Primary Outcome Measures :
  1. Incidence, severity and relationship of treatment-emergent adverse events [ Time Frame: 1 month ]
  2. Incidence, severity and relationship of treatment-emergent adverse events [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Pharmacodynamics [ Time Frame: 16 weeks ]
    Flow cytometry: Change from baseline over time for Tregs, NK cells and CD8+ central memory T-cells

  2. Single-dose and steady-state Cmax [ Time Frame: 16 weeks ]
    Plasma levels of BNZ-1 will be measured after the 1st and last doses

  3. Single-dose and steady-state AUC [ Time Frame: 16 weeks ]
    Plasma levels of BNZ-1 will be measured after the 1st and last doses

  4. Steady-state Elimination half-life (t1/2) [ Time Frame: 16 weeks ]
    Plasma levels of BNZ-1 will be measured after the last dose


Other Outcome Measures:
  1. Exploratory assessment of changes in lesion severity before and after treatment based on the modified Severity Weighted Assessment Tool (mSWAT) [ Time Frame: 16 weeks ]
  2. Exploratory assessment of changes in lesion severity before and after treatment based on the Composite Assessment of Index Lesion Severity (CAILS) scoring tool [ Time Frame: 16 weeks ]
  3. Exploratory assessment of Complete Response in LGL [ Time Frame: 16 weeks ]
    Normalization of CBC and LGL count

  4. Exploratory assessment of Partial Response in LGL defined as 50% improvement in neutrophils or 50% reduction in transfusions [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to consent and participate in the study.
  • Agrees not to receive any other investigational product or therapy while participating in this study.
  • Must be:

    • Currently using two forms of effective birth control (one of which is a barrier method) for the duration of the study for both males and females of childbearing potential. Effective methods of birth control include hormonal contraception (i.e., birth control pills, injected hormones, vaginal ring), intrauterine device, or barrier methods with spermicide (i.e., diaphragm with spermicide, condom with spermicide), or
    • Surgically sterile (i.e., hysterectomy, tubal ligation, vasectomy).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
  • Life expectancy >1 year.

LGL-Specific:

  • Phenotypic studies (obtained within 8 weeks prior to study drug administration) from peripheral blood showing CD3+, CD57+ cells >400/mm³ or CD8+ cells >650/mm³.

    • Note: Complete blood count (CBC) and differential should be reported for the phenotyped sample.
  • Evidence for clonal T-cell receptor gene rearrangement (obtained within 1 year prior to study drug administration).

CTCL-Specific:

  • Histopathologically confirmed mycosis fungoides or Sézary syndrome (CTCL stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (i.e., Refractory) as determined by the Investigator.

Exclusion Criteria:

  • Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
  • History of or currently active primary or secondary immunodeficiency.
  • Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of study drug administration or oral antibiotics within 14 days prior to study drug administration.
  • Received other investigational products or therapy in the 60 days prior to study drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239392


Contacts
Contact: Paul Frohna, MD, PhD (858) 205-5285 paul@bioniz.com

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 10101
Contact: Jaemee Bautista       jbautista@coh.org   
Principal Investigator: Christiane Querfeld, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Elyce Turba       Elyce.Turba@moffitt.org   
Principal Investigator: Lubomir Sokol, MD         
United States, Ohio
The James Cancer Center, Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Hemalatha Rao       hemalatha.rao@osumc.edu   
Principal Investigator: Jonathan Brammer, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Michal Ande       MMA2CZ@hscmail.mcc.virginia.edu   
Principal Investigator: Karen Ballen, MD         
Sponsors and Collaborators
Bioniz Therapeutics
Investigators
Study Director: Paul A Frohna, MD, PhD Bioniz Therapeutics, Inc.

Responsible Party: Bioniz Therapeutics
ClinicalTrials.gov Identifier: NCT03239392     History of Changes
Other Study ID Numbers: BNZ1-CT-201
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bioniz Therapeutics:
BNZ-1
Cytokine
IL-2
IL-15

Additional relevant MeSH terms:
Leukemia
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Neoplasms
Leukemia, T-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases