NCT04883918尚未招募2 期
Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease
ASC Therapeutics0 个研究点目标入组 60 人开始时间: 2023年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Number of adverse events, and serious AEs
研究概览
简要总结
Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT.
Placenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.
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
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 2 months of age
- •Diagnosis of aGVHD grade II-IV following allogeneic HSCT according to standard criteria (Harris, 2016).
- •Diagnosis of SR-aGVHD according to Mohty (2020)
- •Meet one of the following criteria:
- •Participants who are Ruxolitinib-refractory, according to Mohty (2020)
- •Participants who are not eligible for SOC therapy
- •Participants who agree to receive ASC930 as a second-line therapy
- •Karnofsky/Lansky Performance Status of at least 30 at the time of study entry
- •Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).
排除标准
- •Diagnosis of active Hepatic Sinusoidal Obstruction Syndrome (SOS)
- •Presence of an active uncontrolled infection
- •Active treatment for a hyprecoagulation disorder
- •Evidence of diffuse alveolar hemorrhage or other active pulmonary disease
- •Evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD
- •Evidence of relapse of malignancy
- •Receival of agents other than steroids for primary treatment of aGVHD
- •Severe allergic history to cell-based products
结局指标
主要结局
Number of adverse events, and serious AEs
时间窗: 30 days post-infusion
Overall Response Rate (ORR) at Day 28
时间窗: 28 days post-infusion
次要结局
- Complete Response (CR) at Day 28 and Day 180(28 and 180 days post-infusion)
- Duration of response (DOR) at DAY 180(180 days post-infusion)
- Overall survival (OS) rate at DAY 180(180 days post-infusion)
研究者
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