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

Phase 2TerminatedNCT05431907

Enlivex Therapeutics RDO Ltd.9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peritoneal Metastases

Interventions

Allocetra-OTSDRUG

Allocetra-OTS is a cell-based therapy consisting of non-HLA matched allogeneic peripheral blood mononuclear cells, derived from a healthy human donor following a leukapheresis procedure, induced to an apoptotic stable state.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

The Chaim Sheba Medical Center

Ramat Gan, Israel

Outcomes

Primary Outcomes

Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)

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.

Time frame: 16 weeks

Secondary Outcomes

Best Overall Response Rates (BORR)

Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.

Time frame: 16 weeks

Change in specific cancer markers

Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.

Time frame: 16 weeks

Progression-free survival (PFS)

Progression-free survival (PFS) assessed based on imaging data (PET/CT)

Time frame: 6 months

Overall Survival (OS)

OS up to 12 months from the first administration of study treatment.

Time frame: 12 months

Change in quality of life

Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.

Time frame: 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.