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Clinical Trial 19392

Cancer Type:
Interventions:BNZ-1

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Lubomir Sokol

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients with Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma

Summary

The purposes of this study are to: Learn about the safety of BNZ132-1-40 (BNZ-1 for short) in participants with LGL or CTCL. Learn how participants tolerate BNZ-1. Find out how much BNZ-1 is in the participant's blood and for how long. Measure the ability of BNZ-1 to block the cytokine signals in the participant's body Determine if BNZ-1 helps fight the participant's cancer and produces any benefit to participants.

Objective

Primary Objective: The primary objective is to characterize the safety and tolerability of BNZ132-1-40 (BNZ-1) given intravenously (IV) once-weekly to patients with large granular lymphocyte leukemia (LGLL) or refractory cutaneous T-cell lymphoma (rCTCL). Secondary Objectives: The secondary objectives are: To characterize the preliminary clinical response to once-weekly BNZ-1 treatment in patients with LGLL or rCTCL. To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of once-weekly doses of BNZ-1 administered to patients with LGLL or rCTCL.

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.
  • 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/mm^³ or CD8+ cells >650/mm^³. Note: Complete blood count (CBC) and differential should be reported for the phenotyped sample. And - 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 participant 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.