A Phase I Feasibility Study to Evaluate the Safety of CD24-Exosomes in Patients With Moderate/Severe COVID-19 Infection
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Primary safety endpoint: Adverse events
研究概览
简要总结
This is an open-label Phase I study, four dose escalation groups, to evaluate the safety of CD24-exosomes in patients with moderate/severe COVID-19 disease.
Patients with moderate/severe COVID-19 infection and factors predictive of a cytokine storm are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.
详细描述
Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.
CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.
The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, isolated and purified from T-REx™-293 cells engineered to express CD24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. This enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events.
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 85 Years（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
- •Age<18 years or >85 years
- •Any concomitant illness that, based on the judgment of the Investigator is terminal
- •Ventilated patient
- •Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding
- •Unwilling or unable to provide informed consent
- •Participation in any other study in the last 30 days
研究组 & 干预措施
EXO-CD24 exosome treatment
Group 1, 5 patients are treated with 1x10^8 exosome particles per 2 ml saline.
Group 2: 5 patients are treated with 5x10^8 exosome particles per 2 ml saline.
Group 3: 20 patients are treated with 1x10^9 exosomes particles per 2 ml saline.
Group 4: 5 patients are treated with 1x10^10 exosomes particles per 2 ml saline.
The drug is aerosolized in normal saline for inhalation and administered via a standard hospital-grade inhalation device, QD for 5 days. Study treatment is given as an add-on to the standard of care.
干预措施: EXO-CD24 (Drug)
结局指标
主要结局
Primary safety endpoint: Adverse events
时间窗: 35 days
Number of adverse events, and adverse events leading to premature study termination.
次要结局
- Exploratory endpoint: Change in respiratory rate from baseline to Day 5(5 days)
- Exploratory Endpoint: Alive at Day 5 without bronchospasms, unexpected infections, or clinical deterioration(5 days)
- Exploratory endpoint: Proportion of patients with SpO2 saturation ≥94% for at least 24 hours(5 days)
- Exploratory endpoint: Proportion of patients with no artificial ventilation after 5 days of treatment(5 days)
- Exploratory Endpoint: Proportion of patients with respiratory rate ≤ 23/min for 24 hours(5 days)
- Exploratory endpoint: Change in SpO2 saturation from baseline to Day 5(5 days)
- Exploratory endpoint: Proportion of patients with a change in absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment(7 days)
- Exploratory endpoint: Change in the absolute lymphocyte count from baseline to Day 5(5 days)
- Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR), sustained for ≥48 hours after 5 days of treatment(7 days)
- Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5(5 days)
研究者
Eli Sprecher, MD
Nadir Arber MD, MSc, MHA Professor of Medicine and Gastroenterology. Head of the Health Promotion Center and the Integrated Cancer Prevention Center Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center