Clinical trial NCT05431907: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Peritoneal Metastases
Lead sponsor: Enlivex Therapeutics RDO Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and severity of Allocetra-OTS related adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 16 weeks
Secondary outcomes:
measure: Best Overall Response Rates (BORR)
timeFrame: 16 weeks
measure: Change in specific cancer markers
timeFrame: 16 weeks
measure: Progression-free survival (PFS)
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: 12 months
measure: Change in quality of life
timeFrame: 16 weeks
Other outcomes:
measure: Additional Safety Endpoint: Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.
timeFrame: 6 months
measure: Exploratory Endpoint: Change in macrophages and immune cells characteristics in peritoneal fluid
timeFrame: 12 weeks
Locations:
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
affiliation: Department of Surgical Oncology, Sheba Medical Center
name: Avi Nissan, MD
role: PRINCIPAL_INVESTIGATOR
References: