Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients With Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assessment of feasibility
研究概览
简要总结
This early phase I trial identifies the feasibility, possible benefits and/or side effects of administering SARS-CoV-2 specific cytotoxic T lymphocytes (CTLs) in treating cancer patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the virus responsible for coronavirus disease 2019 (COVID-19). SARS-CoV-2 Specific CTLs are a type of immune cells that are made from donated blood cells grown in the laboratory and are designed to kill cells infected with SARS-CoV-2 virus. Giving CTLs may help control the COVID-19 in cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific T cell lines generated by ex vivo expansion as therapy of COVID19 pneumonia in cancer patients.
SECONDARY OBJECTIVES:
I. To obtain preliminary data about the efficacy of administering most closely HLA-matched SARS-COV-2 specific T cell lines generated by ex vivo expansion.
II. To assess the persistence of the administered cells in the 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
- 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
Treatment (SARS-COV-2 specific cytotoxic T cells)
Patients receive SARS-COV-2 specific cytotoxic T lymphocytes IV over 30 minutes on day 1. Treatment may repeat every 14 days at investigators' discretion if patient fails to respond, the infection reoccurs, until the viral load becomes negative or until complete resolution of clinical and radiological signs.
干预措施: SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes (Biological)
结局指标
主要结局
Assessment of feasibility
时间窗: Up to 3 months post-infusion
Proportion of patients who receive at least one severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) specific cytotoxic T lymphocytes (CTLs) infusion. Study approach will be considered feasible if at least 50% of the enrolled eligible patients receive one CTLs infusion.
Incidence of adverse events
时间窗: Up to 3 months post-infusion
Will collect adverse events and grade them according to Common Terminology Criteria for Adverse Events version 4.0. Attribution will be assigned based on the relationship to the cell infusion.
次要结局
- Proportion of subjects alive and free of respiratory failure(At 28 days post-infusion)
- Overall survival(From treatment start date to date of death, assessed up to 3 months post-infusion)
- All-cause mortality(At 28 days post-infusion)
- Cumulative incidence of grade 2-4 or 3-4 graft versus host disease (GVHD), and chronic GVHD(Up to 3 months post-infusion)
- Response to cytotoxic T lymphocytes(Up to 2 weeks post-infusion)
- Relapse free survival (original malignancy)(From treatment start date to the date of documented disease recurrence or death, assessed up to 3 months post-infusion)
- Cumulative incidence of coronavirus disease 2019 pneumonia resolution after therapy(Up to 3 months post-infusion)
- Reconstitution of anti-virus immunity(Up to 3 months post-infusion)