A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 31
- 主要终点
- Safety: Number and severity of AEs and SAEs
研究概览
简要总结
A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
详细描述
Allocetra-OTS is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.
This is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of Allocetra-OTS, in patients with sepsis. The study aims to compare the safety and efficacy of different doses and regimens of Allocetra-OTS, as well as the clinical manifestations following Allocetra-OTS treatment, to that of Placebo in the treatment of organ failure in adult sepsis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years and ≤90 years of age.
- •Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
- •Sepsis due to infection in at least one of the below organs:
- •Community-Acquired Pneumonia (CAP). 3.
- •Urinary tract infection 3.
- •Acute cholecystitis diagnosed by Tokyo criteria 3.
- •Acute cholangitis diagnosed by Tokyo criteria 3.
- •Other intra-abdominal infections (IAI) 3.
- •Skin or soft tissue infection
- •Adequate source control
排除标准
- •Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
- •On chronic dialysis.
- •Patients with acute pancreatitis
- •Moribund patients
- •Weight <50 kg or >120 kg or BMI >40 kg/m^
- •SOFA score ≥14 at screening.
- •Patients with nosocomial infection.
- •A known malignancy.
- •Patients with end-stage disease (unrelated to sepsis)
- •Known active symptomatic SARS-CoV-2 or chronic viral infections, such as HBV or HCV, HIV or other chronic infections.
- •Chronic respiratory disease.
- •Known active upper GI tract ulceration or hepatic dysfunction.
- •Known NYHA class IV heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction.
- •Known immunocompromised state or medications known to be immunosuppressive.
- •Organ allograft or previous history of stem cell transplantation.
研究组 & 干预措施
Cohort 3
Single IV dose of 10x10^9 Allocetra-OTS cells in suspension
干预措施: Allocetra-OTS (Drug)
Cohort 4
Single or two doses of 10x10^9 Allocetra-OTS cells in suspension
干预措施: Allocetra-OTS (Drug)
Cohort 1
Single IV dose of placebo solution
干预措施: Placebo (Other)
Cohort 2
Single IV dose of 5x10^9 Allocetra-OTS cells in suspension
干预措施: Allocetra-OTS (Drug)
结局指标
主要结局
Safety: Number and severity of AEs and SAEs
时间窗: 28 days
Number and severity of AEs and SAEs throughout 28 days follow up period
Efficacy: Change from baseline in SOFA score
时间窗: 28 days
Change from baseline in SOFA score throughout 28 days
次要结局
- Number and severity of AEs and Serious Adverse Events (SAEs)(12 months)
- Days without renal replacement therapy (dialysis).(28 days)
- Number of days with creatinine ≤ Baseline levels +20%(28 days)
- Ventilator-free days(28 days)
- Time in ICU and time in hospital(28 days)
- Changes from baseline in CRP levels(28 days)
- Detection of autoimmune and human leukocyte antigen (HLA) antibodies(12 months)
- Vasopressor-free days(28 days)
- All-cause mortality(28 days)