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

Peritoneal Metastases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05431907
• Other study ID #: ENX-CL-04-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 29, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: April 2024
• Source: Enlivex Therapeutics RDO Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Peritoneal Metastases

Intervention

Drug:
• Allocetra-OTS
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.

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Enlivex Therapeutics RDO Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additional Safety Endpoint: Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.	Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.	6 months
Other	Exploratory Endpoint: Change in macrophages and immune cells characteristics in peritoneal fluid	Change in macrophages and immune cells characteristics in peritoneal fluid and tissues from baseline up to 12 weeks.	12 weeks
Primary	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.	16 weeks
Secondary	Best Overall Response Rates (BORR)	Best Overall Response Rates (BORR) will be comprised of clinical, radiological and pathology assessments.	16 weeks
Secondary	Change in specific cancer markers	Change in the specific cancer markers (CEA, CA-19-9, CA-125) from baseline to each post-PIPAC assessment.	16 weeks
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) assessed based on imaging data (PET/CT)	6 months
Secondary	Overall Survival (OS)	OS up to 12 months from the first administration of study treatment.	12 months
Secondary	Change in quality of life	Change in quality of life according to EORTC QLQ-CR29 from screening to 16 weeks.	16 weeks