Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Dose-Limiting Toxicities
研究概览
简要总结
The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.
详细描述
A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.
The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 to 90 years
- •Tested positive for SARS-CoV-2 <72 hours prior to enrolment
- •Predicted to have high chance of mortality:
- •Group 1: Severe disease, defined by one or more of the following:
- •Respiratory frequency ≥ 30/min
- •Blood oxygen saturation ≤ 93%
- •Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- •Lung infiltrates > 50% within 24 to 48 hours
- •Respiratory failure
- •Septic shock
- •Multiple organ dysfunction or failure
- •Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example,
- •Age > 65 years
- •Chronic health conditions such as chronic lung disease, cardiovascular disease, diabetes mellitus, obesity, end-stage renal disease or liver disease
排除标准
- •Rapidly progressive disease with anticipated life-expectancy <72 hours
- •Receiving steroid (>0.5mg/kg methylprednisolone equivalent)
- •Pregnancy
- •Breastfeeding
结局指标
主要结局
Dose-Limiting Toxicities
时间窗: till Day 28 after infusion of SARS-CoV-2 specific T cells
Dose-limiting toxicities are defined as \>Grade 3 Common Toxicity Criteria associated with the therapeutic cells. Toxicity rate will be summarized descriptively.
次要结局
- Duration of persistence of SARS-CoV-2 specific T cells in the recipient's blood circulation(two months)
- Time to improvement by one category on a WHO ordinal scale(one month)
- National Early Warning Score (NEWS)(one month)
- Time-to-SARS-CoV-2 negativity after infusion of SARS-CoV-2 specific T cells(two months)
- Time-to-normalization of cytokine level, lymphocyte subsets, and gene transcriptome after T cell infusion(two months)
- Overall survival (OS) at 3 months after infusion of SARS-CoV-2 specific T cells(three months)