Phase 0/1 Topical Application of the Monoclonal Antibody (Mab) sB24M in Patients With Severe Pyoderma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Objective response rate (ORR) in patients with severe pyoderma
研究概览
简要总结
Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
详细描述
This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab) sB24M into the areas affected by pyoderma.
Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
This study is a first-in-man since previously no Clinical Studies on the local application (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
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
盲法说明
This trial is an open-label, Phase 0, a non-randomized trial that will enroll up to 10 participants
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed severe form of any type of pyoderma with lesions of the skin and muscle tissue was diagnosed
- •Male or female, age ≥ 21 years
- •Previous treatment with TNF antagonists (infliximab, adalimumab, etanercept, certolizumab, golimumab) ended no earlier than 30 days before starting therapy
- •Secondary treatment failure with up to one previous TNFα antagonist treatment (from the list above)
- •Secondary failure of corticosteroid treatment
- •Adequate hematologic, hepatic, and renal function
- •Written informed consent.
排除标准
- •History of primary resistance or intolerance to any TNFα antagonist.
- •History of congestive heart failure or current, controlled or uncontrolled
- •Women who are pregnant or breastfeeding, or women of childbearing age if no effective method of contraception has been used during and for 3 months after the trial
- •Men, if no effective contraceptive method was used during the study and for 3 months afterward
- •Any prior exposure to Hu5F9-G4 or other CD47 targeting agents
- •Previous allogeneic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or need for graft-associated immunosuppression
- •Refusal to sign the informed consent
结局指标
主要结局
Objective response rate (ORR) in patients with severe pyoderma
时间窗: Approximately 1 year
The ORR is defined as the percentage of participants who had a confirmed Complete Response or Partial Response using RECIST 1.1
次要结局
- Duration of response (DoR) of patients with severe forms of pyoderma(Approximately 1 year)