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Anti-CEA Modified T-Cells


Title Phase Ia/Ib Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer
Therapeutic Area Breast Cancer
Principal Investigator Grace Kao, MD
Min Age 18 Years
Gender Both
Contact Liz Kendricken, RN
617-636-5558
More Information clinicaltrials.gov/ct2/show/NCT00673829

Overview

The purpose of this study is to test the safety of modified (changed) T-cells and to determine the type and severity of any side effects there may be. Based on previous laboratory studies, investigators believe that T-cells (white blood cells that normally function to control the immune system and fight viral infections) that are modified in the laboratory may be helpful in breast cancer. They are modified and designed to program the immune system to attack cancer.

Study Details

Inclusion Criteria

  • 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 failed potentially curative standard therapy

Exclusion Criteria

  • Requiring systemic steroids
  • Serious medical conditions
  • Concurrent malignancies

Study Requirements

Participants will receive a fixed dose of gene-modified T cells and be randomized to receive T cell growth factor interleukin 2 (+IL2) or not. The IL2 is administered outpatient by continuous infusion pump for a four-week period. On Day +2 and Day +10, the participant's tumor is biopsied to assess the designer T cell presence in the tumor as a means of judging the benefit of added IL2. Participants will also be followed for tumor response and will have blood draws/test, EKGs and other test as needed per protocol.