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

Enlivex Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Peritoneal Metastases

Treatments: Drug: Allocetra-OTS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05431907

ENX-CL-04-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Cohorts 1-2

Experimental group

Description:

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

Treatment:

Drug: Allocetra-OTS

Cohorts 3-4

Experimental group

Description:

Allocetra-OTS at the maximal tolerated dose.

Treatment:

Drug: Allocetra-OTS