Study to Investigate Safety, Efficacy of Novel Cell Therapy Plus Chemo in Cancer That Spread to the Abdominal Cavity

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According to the manufacturer, this is the first-in-human clinical trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers.

The first patient has been treated with standard-of-care chemotherapy in combination with a novel cell therapy known as Allocetra for solid tumors with peritoneal metastases, which is cancer that has spread to the abdominal cavity.

Whether it’s the primary tumor or cancer that has spread to the peritoneum, peritoneal cancer is often associated with a poor prognosis, according to a news release from Allocetra’s manufacturer, Enlivex Therapeutics.

Depending on the location of the primary solid cancer, median survival rates differ but are considered poor. For instance, according to the release, patients with pancreatic cancer that has spread to the peritoneum have a median survival rate of 2.9 months.

“The patients are operated using the pressurized intra-peritoneal aerosol chemotherapy (PIPAC) technology, which allows for efficient insertion of therapeutics directly to the peritoneum,” lead study author Dr. Aviram Nissan, head of the Department of General and Oncological Surgery at Sheba Medical Center in Ramat Gan, Israel, said in the release. “We hope that the combination of chemotherapy and Allocetra, a next-generation cell therapy in development for oncological indications, will generate a breakthrough in the treatment of peritoneal metastases, which are not treatable in most patients with anti-cancer drugs available today. We are eager to test this new combination with the hope of changing the lives of patients with peritoneal metastases.”

The early-phase trial, according to the release, will comprise 12 patients across four treatment groups. The main goal is to investigate the safety and possibly preliminary efficacy of the combination in the group of patients.

The treatment is delivered directly into the abdominal cavity via an aerosol spray. During the 16-week study period, investigators will be looking to identify the number and severity of side effects related to treatment with Allocetra. They will also be assessing best overall response rates (percentage of patients whose tumors respond to treatment), progression-free survival (time patients are alive without disease progression) and overall survival (time a patient is alive until death from any cause).

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