Phase 1/2 Study Evaluating Safety and Potential Efficacy of Allocetra-OTS Via Pressurized Intra-Peritoneal Aerosol Chemotherapy as Add-on to Standard of Care Chemotherapy for Treatment of Peritoneal Metastasis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is an open-label study to evaluate safety and potential efficacy of Allocetra-OTS in the treatment of patients with peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy.
详细描述
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is utilized in patients with malignant dissemination to the peritoneal cavity, for the treatment of peritoneal metastasis that have a high tumor burden or are unresectable, and are unresponsive to systemic therapy.
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.
The study will evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of peritoneal metastasis as an add-on to the standard of care (SoC) chemotherapy. Patients will be treated with escalating doses of Allocetra-OTS as an add-on to the chemotherapy administered via PIPAC, and in addition to systemic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •18 years of age or older.
- •Diagnosis of peritoneal metastasis due to any primary tumor by histopathology or cytology
- •Possession of unresectable tumors (not eligible for Cytoreductive Surgery / Hyperthermic Intra-Peritoneal Chemoperfusion CRS/HIPEC).
- •Adequate performance status and surgical risk
- •Adequate hematopoietic, hepatic and renal function
排除标准
- •Extraperitoneal disease.
- •Bowel obstruction
- •History of Liver cirrhosis with CHILD PUGH classification of B or C or signs of portal hypertension, portal vein thrombosis.
- •Patient with known New York Heart Association (NYHA) class 3 or 4 symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
- •Previous history of organ allograft or stem cell transplantation.
研究组 & 干预措施
Cohorts 1-2
Escalating doses of Allocetra-OTS up to 10 x 10^9 cells.
干预措施: Allocetra-OTS (Drug)
Cohorts 3-4
Allocetra-OTS at the maximal tolerated dose.
干预措施: Allocetra-OTS (Drug)
结局指标
主要结局
Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)
时间窗: 16 weeks
Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs) during 16-week period starting from the first administration of study treatment.
次要结局
- Change in quality of life(16 weeks)
- Best Overall Response Rates (BORR)(16 weeks)
- Progression-free survival (PFS)(6 months)
- Overall Survival (OS)(12 months)
- Change in specific cancer markers(16 weeks)