NCT03332121已完成1 期
Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of B001 as assessed by adverse reactions and events
研究概览
简要总结
It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.
详细描述
Phase I dose escalation study
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-75, male or female.
- •Patients with the following histologically-documented hematologic malignancy: CD20 positive B-cell non Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to 2016 WHO Classification of Lymphoma.
- •Patients with relapsed/refractory CD20 positive B cell NHL (including CLL/SLL )
- •Life expectancy of at least 6 months.
- •ECOG-PS score of 0-
- •For patients of reproductive potential, pregnancy test should be negative 7 days before treatment , and use of a reliable means of contraception during the study and 12months after discontinuing treatment. Males should be willing to use barrier contraception during the study and 12months after discontinuing treatment.
- •Provision of signed and dated ,written informed consent prior to any study specific procedures, sampling and analyses.
排除标准
- •Serious blood, renal or hepatic function impairment:
- •Absolute neutrophil count(ANC)<1.0*10^9/L（Except for those with bone marrow invasion）
- •Lymphocyte Count(LYM)>50*10^9/L
- •Haemoglobin(Hb)<70g/L（Except for those with bone marrow invasion）
- •Platelet count(PLT)<50*10^9/L（Except for those with bone marrow invasion）
- •Creatinine (Cr)>1.5xULN
- •Alanine transaminase (ALT)or Aspartate aminotransferase(AST)>2.5xULN
- •Total bilirubin (TBIL)>2xULN
- •Patients with any anti-tumor treatment (including steroid treatment) within 4 weeks or with any chronic unresolved toxicities from prior therapy greater than Grade 2 according to NCI-CTCAE 4.
- •Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.
- •received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.
- •Radiotherapy within 3 months.
- •Major surgery within 28 days
- •History of tumor vaccine treatment.
- •Live-virus (live attenuated) vaccine treatment within 28 days
- •High dose of steroid treatment (hydroprednisone >10mg/day or relevant dose of other drugs)
- •Patients with history of hematopoietic stem cell transplantation or planning to receive hematopoietic stem cell transplantation within 3 months.
- •Patients with history of Gastrointestinal perforation and/or fistula within 6 months.
- •Lymphoma in CNS, ADIS related lymphoma
- •Active infection by bacteria,virus,fungus which required hospitalization or severe infection required intravenous administration of antibiotics
- •Concomitant severe disease including but not limited to:
- •Known HIV or ADIS related disease
- •Asthma or interstitial lung disease or severe COPD
- •Myocardial infarction, unstable angina, Cardiovascular interventional surgery, Congestive heart failure(CHF; NYHA Grade II-IV), symptomatic or poorly controlled arrhythmia within 6 months before enrolling
- •The systolic pressure ≥140mmHg,or diastolic pressure≥90mmHg post treatment.
- •Acute or chronic hypotension(<90/60mmHg)
- •History of toxic epidermal necrolysis or Stevens-Johnson syndrome
- •Rheumatoid arthritis Granulomatous angiitis or microscopic polyangiitis
- •Ileus or history of following disease: inflammatory bowel disease or extensive intestinal resection(extensive bowel resection or hemicolectomy, combining chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
- •Previous or concomitant malignant, except basal-cell carcinoma or squamous cell carcinoma and/or cervical carcinoma in situ or effectively treated hematological malignancy and solid tumor that has been remission for more than 3 years and is considered to be cured.
- •Any history may affect the study result: increasing dosing risk or affect lab values and Judgment by the investigator that the patient should not participate in the study,
- •HBsAg positive; HBcAb positive and HBV-DNA≥upper limit of detection, HCV positive; HIV positive
- •Allergy to humanized antibody or human-mouse chimeric antibody.
- •Woman who are breast feeding or pregnant
- •Judgment by the investigator that the patient should not participate in the study
结局指标
主要结局
Safety of B001 as assessed by adverse reactions and events
时间窗: 42 days
Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001
次要结局
- PD results of B001(112 days)
- Concentration-time curve of B001(112 days)
- ORR of B001(112 days)
- Immunogenicity of B001(112 days)
研究者
研究点 (2)
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