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

NCT05431907 | Terminated Phase 1 DMC

• 1 other identifier: ENX-CL-04-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Best Overall Response Rates (BORR)

  16 weeks

• Change in specific cancer markers

  16 weeks

• Progression-free survival (PFS)

  6 months

• Overall Survival (OS)

  12 months

• Change in quality of life

  16 weeks

Other Outcomes (2)

• Additional Safety Endpoint: Number and severity of related AEs and SAEs throughout 6 months from the first administration of study treatment.

  6 months

• Exploratory Endpoint: Change in macrophages and immune cells characteristics in peritoneal fluid

  12 weeks

Study Arms (2)

Cohorts 1-2

EXPERIMENTAL

Escalating doses of Allocetra-OTS up to 10 x 10\^9 cells.

Drug: Allocetra-OTS

Cohorts 3-4

EXPERIMENTAL

Allocetra-OTS at the maximal tolerated dose.

Drug: Allocetra-OTS

Interventions

Allocetra-OTS DRUG

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.

Cohorts 1-2; Cohorts 3-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enlivex Therapeutics RDO Ltd.: lead

Study Sites (1)

The Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Study Officials

• Avi Nissan, MD

  Department of Surgical Oncology, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 24, 2022
• Study Start: June 29, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)