A Phase 1 Study of agenT-797 to Treat Moderate to Severe Acute Respiratory Syndrome in COVID-19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events
研究概览
简要总结
A Phase 1 study of agenT-797 to treat moderate to severe acute respiratory syndrome in Coronavirus disease 2019 (COVID-19) participants.
详细描述
This is a Phase 1 study to evaluate the safety and efficacy of agenT-797, an unmodified, allogeneic invariant natural killer T cells (iNKT) therapy, in participants with COVID-19, requiring mechanical ventilation, and with moderate to severe acute respiratory distress syndrome (ARDS) as determined by the Berlin definition.
The study will be conducted in 2 parts. Part 1 will employ a standard 3+3 dose escalation design of agenT-797. All participants will receive a single infusion of agenT-797. Participants will also receive other treatments and supportive care per discretion of the principal investigator. Once the maximum tolerated dose of agenT-797 has been cleared in Part 1, Part 2 of the study will be opened and enroll eligible participants in the Expansion Cohort.
A safety monitoring committee will be established to assess safety and decide on escalation to next cohort and expansion dose, as well as any protocol modification to include less severe cases.
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
- •Voluntarily agree to participate and ability to provide informed consent or have duly appointed health care proxy with the authority to consent.
- •Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by polymerase chain reaction test or equivalent approved test.
- •Inpatient hospitalization.
- •Evidence of SARS-CoV-2 infection with the diagnosis of moderate to severe ARDS per Berlin definition, no more than 2 weeks prior to study enrollment.
- •Participants, or duly appointed health care proxy with the authority to consent, must consent to placement of a central venous access line for the administration of agenT-797.
排除标准
- •Currently participating and receiving study therapy of an investigational agent that is not registered for any other indication. Note: Participants may receive the standard of care for SARS-CoV-2 infection as per institutional practices.
- •Presence of comorbidities limiting expected survival of <1 month.
- •Any comorbidity which in the opinion of the investigator may preclude/confound study required safety and efficacy assessments.
- •Clinically significant cardiomyopathy.
- •Receipt of non-oncology vaccines containing live virus for prevention of infectious diseases within 4 weeks prior to first dose of study treatment.
- •Known hypersensitivity to natural killer cells or their preservation solution.
- •Active systemic bacterial or fungal infection or viral co-infection.
- •Legally incapacitated or has limited legal capacity.
- •Pregnant or lactating women.
研究组 & 干预措施
Dosage and Cohorts
Cohort 1: 100 × 10^6 iNKT cells; Cohort 2: 300 × 10^6 iNKT cells; Cohort 3: 1000 × 10^6 iNKT cells
Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized participants as a single intravenous infusion.
干预措施: agenT-797 (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events
时间窗: Baseline through Month 6
Number of Participants with Dose-limiting Toxicities
时间窗: Baseline through Month 6
次要结局
- Time to Extubation(Up to Day 30)
- Change from Baseline in C-reactive Protein (CRP)(Baseline through Day 30 (every 12 hours, as feasible))
- All-cause Mortality(Day 30 and Month 6)
- Decay in Quantitative Viral Burden from Upper and Lower Respiratory Tract Samples(Day 30)
- Change from Baseline at Day 30 in Number of Allogeneic iNKT Cells(Baseline, Day 30)