NCT03239392已完成1 期
A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma
Bioniz Therapeutics4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence, severity and relationship of treatment-emergent adverse events
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
BNZ-1
Experimental
IV PEGylated BNZ132-1-40
干预措施: BNZ132-1-40 (Drug)
结局指标
主要结局
Incidence, severity and relationship of treatment-emergent adverse events
时间窗: 4 months
次要结局
- Pharmacodynamics(16 weeks)
- Single-dose and steady-state AUC(16 weeks)
- Steady-state Elimination half-life (t1/2)(16 weeks)
- Single-dose and steady-state Cmax(16 weeks)
研究者
研究点 (4)
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