NCT02206308已完成1 期
A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Number of participants with infusion-related reaction and with drug-related adverse events.
研究概览
简要总结
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
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
- •aged from 18 to 75 years
- •having histologically confirmed NHL expressing CD20 antigen
- •having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months
- •signed an informed consent form which was approved by the institutional review board of the respective medical center
排除标准
- •single measurable lesion ≥7 cm in diameter
- •with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN )
- •having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
- •had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- •had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
- •with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
- •having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
- •with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
- •with a history of allergic reaction or protein product allergy including murine proteins
- •pregnant or lactating or not accepted birth control methods including male patients
结局指标
主要结局
Number of participants with infusion-related reaction and with drug-related adverse events.
时间窗: up to 27 weeks
次要结局
- Area Under the plasma concentration versus time curve (AUC) of SCT400(prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose)
研究者
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