NCT05581719

A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Enlivex Therapeutics RDO Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy or in combination with an anti-PD-1 therapy.

Detailed description

Despite the advent of novel targeted and immunotherapeutics for the treatment of solid tumors, many patients remain without cure. 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. This is an open-label, non-randomized, multicenter, Phase 1/2a study to evaluate the safety and potential efficacy of Allocetra-OTS in the treatment of advanced solid tumor malignancy as monotherapy (Stage 1), and in combination with an anti-PD-1 therapy (Stage 2). Allocetra-OTS will be administered systemically or locally (intravenous \[IV\] or intraperitoneal \[IP\]) according to the tumor location.

Conditions

• Solid Tumor
• Peritoneal Metastases
• Peritoneal Cancer

Interventions

Type	Name	Description
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.
DRUG	Nivolumab	Immune checkpoint inhibitor (anti-PD-1 antibody)
DRUG	Tislelizumab	Immune checkpoint inhibitor (anti-PD-1 antibody)

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2022-10-14
• Last updated: 2024-04-17

Locations

6 sites across 2 countries: Israel, Spain