Spots Global Cancer Trial Database for CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

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Trial Identification

Brief Title: CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)

Official Title: Immunotherapy for Peritoneal Carcinomatosis (IPC) - A Phase I Study of the Safety and Efficacy of Anti-CEA CAR-T Cell Intraperitoneal Infusions for Treatment of CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites

Study ID: NCT03682744

Conditions

Peritoneal Carcinomatosis

Peritoneal Metastases

Carcinoembryonic Antigen

Interventions

anti-CEA CAR-T cells

Study Description

Brief Summary: This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.

Detailed Description: Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by intraperitoneal infusion at specific cell doses. One anti-CEA CAR-T dose per patient is planned. Additional cycles may be administered at the discretion of the principal investigator. Normal peritoneal and tumor biopsies will be obtained at the time of the CAR-T infusion, on the final day of the treatment period, and during reporting interval #3.