drugset / Trial / NCT01373047

CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells

NCT01373047 ↗

Phase 1 Completed 8 enrolled Roger Williams Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. The investigators hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.

Timeline

Start
2011-06
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-CEA 2nd generation designer T cells Cell therapy 1e+08 cells Other
Subject anti-CEA 2nd generation designer T cells Cell therapy 1e+09 cells Other
Subject anti-CEA 2nd generation designer T cells Cell therapy 1e+10 cells Other

Indications