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CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases — HITM-SIR  

Liver Metastases Clinical Trial

Official title:
Phase Ib Trial of CAR-T Hepatic Artery Infusions Followed by Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Sir-Spheres® for CEA-Expressing Liver Metastases

Clinical Trial Summary

This is an open label fixed dose phase Ib of anti-CEA CAR-T cells hepatic artery infusions and yttrium-90 SIR-Spheres in patients with CEA-expressing liver metastases.

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 percutaneous hepatic artery infusion at specific cell doses. Prior to the first dose, each patient will undergo diagnostic angiography to verify suitable arterial anatomy. Three anti-CEA CAR-T doses and one SIR-Sphere dose per patient are planned at 2-week intervals. Low dose interleukin-2 will be given via an ambulatory infusion pump for 6 weeks.Normal liver and tumor biopsies will be obtained at the time of the initial diagnostic angiogram and during the final infusion session. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02416466
Study type Interventional
Source Roger Williams Medical Center
Contact
Status Completed
Phase Phase 1
Start date April 2015
Completion date June 2018
View Details
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