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
- Registration Number
- NCT05431907
- Lead Sponsor
- Enlivex Therapeutics RDO Ltd.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohorts 3-4 Allocetra-OTS Allocetra-OTS at the maximal tolerated dose. Cohorts 1-2 Allocetra-OTS Escalating doses of Allocetra-OTS up to 10 x 10\^9 cells.
- Primary Outcome Measures
Name Time Method Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs) 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.
- Secondary Outcome Measures
Name Time Method Change in quality of life 16 weeks Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.
Best Overall Response Rates (BORR) 16 weeks Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.
Progression-free survival (PFS) 6 months Progression-free survival (PFS) assessed based on imaging data (PET/CT)
Overall Survival (OS) 12 months OS up to 12 months from the first administration of study treatment.
Change in specific cancer markers 16 weeks Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.
Trial Locations
- Locations (1)
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel