An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Advanced Stage (IIA-IVB) Cutaneous T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Genmab
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
研究概览
简要总结
The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by late stage CTCL have many cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all participants will be treated with HuMax-CD4. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HuMax-CD4 280 milligrams (mg)
干预措施: HuMax-CD4 (Drug)
HuMax-CD4 980 mg
干预措施: HuMax-CD4 (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
时间窗: Up to 20 weeks
次要结局
- Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response(Up to 20 weeks)
- Time to Response(From first dose to achieving a response (up to approximately 12 weeks))
- Number of Participants with Adverse Events (AEs) and Graded as per Severity(From Baseline (Day 0) up to end of study (Week 20))
- Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres(Up to Week 20)
- Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)(Baseline up to Week 21)
- Percentage of Participants with Change from Baseline in Participant's Assessment of Pruritus Scale(Baseline, up to Week 20)
- Response Duration(From achieving first response to last response/until relapse (up to approximately 22 weeks))
- Time to Disease Progression(From first dose until disease progressed (Up to 16 weeks))
- Change from Baseline in Physician's Erythroderma Severity Assessment(Baseline, Week 20)