Clinical Trials /

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

NCT03239392

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 Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).

Related Conditions:
  • Primary Cutaneous T Cell Non-Hodgkin Lymphoma
  • Sezary Syndrome
  • T-Cell Large Granular Lymphocyte Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BNZ1-CT-201
  • NCT ID: NCT03239392

Conditions

  • LGL Leukemia
  • CTCL

Interventions

DrugSynonymsArms
BNZ132-1-40BNZ-1BNZ-1

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
BNZ-1ExperimentalIV PEGylated BNZ132-1-40
  • BNZ132-1-40

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence, severity and relationship of treatment-emergent adverse events
Time Frame:1 month
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pharmacodynamics
Time Frame:16 weeks
Safety Issue:
Description:Flow cytometry: Change from baseline over time for Tregs, NK cells and CD8+ central memory T-cells
Measure:Single-dose and steady-state Cmax
Time Frame:16 weeks
Safety Issue:
Description:Plasma levels of BNZ-1 will be measured after the 1st and last doses
Measure:Single-dose and steady-state AUC
Time Frame:16 weeks
Safety Issue:
Description:Plasma levels of BNZ-1 will be measured after the 1st and last doses
Measure:Steady-state Elimination half-life (t1/2)
Time Frame:16 weeks
Safety Issue:
Description:Plasma levels of BNZ-1 will be measured after the last dose

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bioniz Therapeutics

Trial Keywords

  • BNZ-1
  • Cytokine
  • IL-2
  • IL-15

Last Updated

July 12, 2019