Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer

Paused · Phase 1

Conditions studied: Breast Cancer

In brief

The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with breast cancer. 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 to the participant so that they can attack and kill tumor cells.

Key facts

Study ID

NCT00673829

Run by

Roger Williams Medical Center

People needed

26

Starts

2008-05-01

Expected to finish

2018-12-01

Last updated by the study team

2016-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have cancer of the breast
• Must have metastatic or unresectable locally advanced disease
• Tumor must express CEA by tumor staining or by elevated serum CEA (>10 ng/ml)
• Must have measurable disease radiologically or by physical exam
• Must have failed potentially curative standard therapy
• Must be 18 years of age or older
• Good performance status (PS 0-1)

You may not qualify if…

• Requiring systemic steroids
• Serious medical conditions
• Concurrent malignancies

Where it is running

• Tufts University Medical Center — Boston, Massachusetts, United States
• Roger Williams Medical Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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