NCT03218072已完成1 期
A Phase Ia, Multi-centers, Open-label, Dose-escalation Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HLX01 (a Potential Rituximab Biosimilar) in Patients With CD20-positive B-cell Lymphomas
Shanghai Henlius Biotech0 个研究点目标入组 12 人开始时间: 2014年5月4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
- 12
- 主要终点
- AEs
研究概览
简要总结
To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.
详细描述
This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ aged ≤ 65 years, male or female;
- •having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
- •providing signed and dated informed consents.
排除标准
- •Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
- •usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
- •recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
- •peripheral nervous system diseases or central nervous system diseases;
- •inadequate hematologic function met any of the following at screening: white blood cell count <3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) <1.0×109/L, platelet count <75×109/L, hemoglobin <80 g/L;
- •inadequate liver function met any of the following at screening: total bilirubin>1.5×the upper limit of normal range (ULN), ALT or AST>2.0×ULN, alkaline phosphatase (ALP)>3.0×ULN;
- •abnormal renal function (serum creatinine>1.5×ULN);
- •abnormal thyroid function (TSH< lower limit of normal or > upper limit of normal with clinical significance judged by investigators);
- •positive test result(s) for serum HIV antigen or antibody;
- •seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA>ULN; seropositivity of Anti HCV antibody;
- •history of herpes zoster and left with sequelae or latent infection;
- •other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
- •pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
- •allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
- •history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
- •not suitable for enrollment at investigator's discretion.
研究组 & 干预措施
HLX01 250 mg/m2
Experimental
HLX01 250 mg/m2 administrated intravenously
干预措施: HLX01 (Drug)
HLX01 375 mg/m2
Experimental
HLX01 375 mg/m2 administrated intravenously
干预措施: HLX01 (Drug)
HLX01 500 mg/m2
Experimental
HLX01 500 mg/m2 administrated intravenously
干预措施: HLX01 (Drug)
结局指标
主要结局
AEs
时间窗: From First infusion to Day 90
The type, severity and incidence of adverse events
SAEs
时间窗: From First infusion to Day 90
Thetype, severity and incidence of SAEs
次要结局
- AUC0-inf(From First administration to Day 90)
- CD19 positive B cells(From First administration to Day 90)
- CD20 positive B cells(From First administration to Day 90)
- Cmax(From First administration to Day 90)
- t1/2(From First administration to Day 90)
- Antidrug antibodies of HLX01(From First administration to Day 90)
研究者
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