NCT03682744

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peritoneal Carcinomatosis
• Peritoneal Metastases
• Colorectal Cancer
• Gastric Cancer
• Breast Cancer
• Pancreas Cancer
• Carcinoembryonic Antigen

Interventions

Type	Name	Description
BIOLOGICAL	anti-CEA CAR-T cells	Intraperitoneal delivery of anti-CEA CAR-T cells

Timeline

• Start date: 2018-09-13
• Primary completion: 2020-12-01
• Completion: 2021-03-01
• First posted: 2018-09-25
• Last updated: 2022-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study