The multicentre, dose escalation, open-label trial has been designed for assessing the tolerability, safety, and preliminary efficacy of the cell therapy and the combination.
Up to 48 subjects with advanced solid tumours are expected to be enrolled in the trial across two stages.
The first stage will investigate escalating Allocetra monotherapy doses administered intravenously (IV) or intraperitoneally (IP) once weekly for three consecutive weeks.
In the second stage, escalating doses of the therapy administered IV or IP and combined with anti-PD1 therapy will be evaluated.
In this stage, patients will be given three Allocetra injections concomitantly with the studied anti-PD1 agent.
Assessment of safety and tolerability throughout the treatment period and through one week following the last administration of the therapy is the study’s primary objective.
Efficacy evaluations such as progression-free survival, best overall response rate, and overall survival are the key secondary endpoints.
Variations in immune cell/cytokine profiling in peritoneal fluid will also be evaluated as an exploratory endpoint.
The study will enrol adult advanced, unresectable, or metastatic solid tumour patients.
Tumours in these patients have relapsed or have been refractory to available therapies that have approvals in place.
Subjects not eligible for, or who have declined additional standard-of-care systemic therapy, will also be part of the trial.
Enlivex CEO Oren Hershkovitz said: “Our team is continuing to focus on execution of our strategic and operating plan across our various clinical development verticals, with an ongoing sepsis Phase II clinical trial and two ongoing oncology Phase I/II clinical trials.
“We believe that Allocetra has the potential to provide a paradigm shift in treatment of advanced solid tumours, and we look forward to observing safety and potential indication of effect in patients, who we expect to enrol in our open-label oncology trials during 2023.”
Allocetra is being developed as a universal, off-the-shelf cell therapy.
In August this year, Enlivex received the Israeli Ministry of Health (MOH) approval to commence the Phase I/II clinical trial of Allocetra as a monotherapy, and along with a PD1 checkpoint inhibitor, in patients with advanced solid tumours.
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