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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 25, 2021

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

July 31, 2017

Last Update Submit

May 24, 2021

Conditions

LGL LeukemiaCTCL

Keywords

BNZ-1CytokineIL-2IL-15

Outcome Measures

Primary Outcomes (2)

  • Incidence, severity and relationship of treatment-emergent adverse events

    1 month

  • Incidence, severity and relationship of treatment-emergent adverse events

    4 months

Secondary Outcomes (4)

  • Pharmacodynamics

    16 weeks

  • Single-dose and steady-state Cmax

    16 weeks

  • Single-dose and steady-state AUC

    16 weeks

  • Steady-state Elimination half-life (t1/2)

    16 weeks

Other Outcomes (3)

  • Exploratory assessment of changes from baseline in CTCL disease severity (mSWAT)

    16 weeks

  • Exploratory assessment of Complete Response in LGL

    16 weeks

  • Exploratory assessment of Partial Response in LGL

    16 weeks

Study Arms (1)

BNZ-1

EXPERIMENTAL

IV PEGylated BNZ132-1-40

Drug: BNZ132-1-40

Interventions

BNZ132-1-40DRUG

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

Also known as: BNZ-1
BNZ-1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

City of Hope National Medical Center

Duarte, California, 10101, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

The James Cancer Center, Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Brammer JE, Ballen K, Sokol L, Querfeld C, Nakamura R, Mishra A, McLaughlin EM, Feith D, Azimi N, Waldmann TA, Tagaya Y, Loughran T. Effective treatment with the selective cytokine inhibitor BNZ-1 reveals the cytokine dependency of T-LGL leukemia. Blood. 2023 Oct 12;142(15):1271-1280. doi: 10.1182/blood.2022017643.

    PMID: 37352612DERIVED

MeSH Terms

Conditions

Leukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Leukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jonathan Brammer, MD, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 4, 2017

Study Start

April 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 25, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months after study data analysis is completed and a CSR has been generated

Locations

US(4)