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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03682744
Study type Interventional
Source Sorrento Therapeutics, Inc.
Contact
Status Withdrawn
Phase Phase 1
Start date September 13, 2018
Completion date March 2021

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