Enlivex Therapeutics has received the Israeli Ministry of Health (MOH) authorisation to initiate a Phase I/II clinical trial of its cell therapy Allocetra along with chemotherapy in patients with peritoneal metastases arising from solid cancer.
The company-sponsored, open-label dose escalation and expansion trial of the universal, off-the-shelf therapy is expected to enroll a total of nearly 12 patients across four cohorts.
It will assess the potential preliminary efficacy and safety of Allocetra and SOC chemotherapy combination in peritoneal metastases patients.
For determining the maximum feasible dose (MFD) of Allocetra, the trial will begin with two cohorts of intra-patient and intra-cohort dose escalation.
This will be followed by another two cohorts to compare the therapy administration at the selected dose either before or after administration of SOC through a pressurised intraperitoneal aerosol chemotherapy procedure (PIPAC).
Enlivex Therapeutics Medical vice-president Einat Galamidi said: “Our preclinical studies suggest Allocetra may enhance the efficacy of a broad range of therapeutic agents by weakening tumour defense mechanisms through a novel mechanism of action that drives macrophage populations towards a more anti-cancer state.
“We look forward to beginning the clinical evaluation of this hypothesis through both this chemotherapy combination study and an additional planned solid tumour study that will evaluate Allocetra combined with a checkpoint inhibitor.”
Every six weeks, the trial subjects will receive intraperitoneally delivered Allocetra and SOC chemotherapy administered through the PIPAC technique.
As per the treatment plan of the oncologist, they will also receive systemic chemotherapy.
Number and severity of Allocetra-related and serious adverse events during the 16-week period is the primary endpoint of the trial.
Efficacy assessments, such as best overall response rate (ORR), overall survival and progression-free survival are included as secondary endpoints.
Evaluation of variations from baseline in macrophage and immune cell characteristics in peritoneal fluid and tissues will be considered as an exploratory endpoint.
Enlivex plans to initiate the Phase I/II trial of Allocetra and chemotherapy combination in the third quarter of this year and also expects to initiate a Phase I/II trial of the therapy along with an immune checkpoint inhibitor late this year.
In August last year, Enlivex announced a Phase IIb trial of Allocetra in severe and critical Covid-19 patients with acute respiratory distressed syndrome.
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