"Phase II/Pilot Study of 2nd Generation Anti-CEA Esigner T Cells in Adenocarcinomas"
CEA is perhaps the most prominent tumor marker among malignancies of epithelial origin:
colorectal carcinoma, with 60-94% of tumors positive in patients with advanced disease;
breast carcinoma, with 30-60% of metastatic cases positive for CEA; and cancers of the lung,
liver, pancreas, head and neck, bladder, cervix and prostate with 30% or more with CEA+
The application of these therapies in the four Phase II/Pilot clinical sub studies listed
below proceed after collecting patient lymphocytes by leukapheresis, which are then modified
by transfer of the chimeric gene for Ig-CD28-TCRzeta. Cells are selected in culture with
amplification and activation of the now-specific anti-tumor T cells. These are then re
infused into the patients, with IL2 supplementation, and toxicity and response are
There are four sub studies embedded within this Phase II Study of Second Generation Designer
T Cells in CEA-expressing Adenocarcinomas. The embedded studies are:
- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Gastric
- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Colorectal
- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Lung Cancers
- A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Solid Tumors
A total of 12 subjects per protocol or a total of 48 subjects will be enrolled combining the
enrollment of the 4 CEA-expressing protocols.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Monitoring of CEA levels, pre and post infusion of T cells. Monitoring of CT and PET scans pre and post infusion.
Richard P Junghans, PhD, MD
Roger Williams Medical Center
United States: Food and Drug Administration
|Roger Williams Medical Center||Providence, Rhode Island 02908-4735|