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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05581719
Study type Interventional
Source Enlivex Therapeutics RDO Ltd.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date November 15, 2022
Completion date April 15, 2024

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