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NCT01373047 · ClinicalTrials.gov registry record · Phase 1
CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells
A Phase 1 study, sponsored by Roger Williams Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01373047 is a Phase 1 study that has completed, run by Roger Williams Medical Center. The registered enrollment target is 8 participants.
The verdict
NCT01373047, a Phase 1 study, has completed, sponsored by Roger Williams Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL anti-CEA 2nd generation designer T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01373047
The ClinicalTrials.gov registry entry for NCT01373047 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roger Williams Medical Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which anti-CEA 2nd generation designer T cells is the first listed.
NCT01373047 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01373047 about?
NCT01373047 is a clinical study titled "CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells". 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 p...
What is the current status of trial NCT01373047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-06. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01373047?
The interventions under investigation include: anti-CEA 2nd generation designer T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01373047?
This trial is sponsored by Roger Williams Medical Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
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