Enlivex Therapeutics has received approval from the Israeli Ministry of Health (MOH) to commence the Phase I/II clinical trial of Allocetra as a monotherapy, and along with a PD1 checkpoint inhibitor, in advanced solid tumour patients.

Sponsored by the company, the open-label, multicentre, dose-escalation trial will analyse the safety, tolerability, and initial efficacy of Allocetra alone and in combination with a PD1 agent.

It is anticipated to enrol up to 48 subjects in two study stages. 

The trial’s Stage 1 will assess escalating doses of Allocetra given intravenously (IV) or intraperitoneally (IP) weekly for three successive weeks. 

Escalating doses of IV or IP Allocetra, along with anti-PD1 therapy, will be analysed in Stage 2.

Subjects in this stage will be given three doses of Allocetra along with the anti-PD1 agent. 

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Assessing the safety and tolerability along the treatment duration and through one week following the last dose of Allocetra is the trial’s primary objective.

Efficacy evaluations such as progression-free survival, overall response rate, and overall survival comprise the key secondary endpoints. 

As an exploratory endpoint, variations in immune cell/cytokine profiling in the peritoneal fluid will be analysed.

Being developed as a universal, off-the-shelf cell therapy, Allocetra could potentially reprogramme macrophages into their homeostatic state. 

Enlivex Medical vice-president Einat Galamidi said: “With Allocetra treatment, we aim to change the balance of macrophage populations surrounding the solid tumour environment in favour of anti-cancer activity, in order to overcome the biological mechanisms underlying checkpoint inhibitor resistance. 

“Collaborative studies with Yale Cancer Center have generated meaningful preclinical data, suggesting we may be successful in these efforts, with Allocetra and an anti-PD1 agent synergistically combining, which delivered a statistically significant survival benefit in a murine model of ovarian cancer.”

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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