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Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer


T cells can penetrate virtually every biologic space and have the power to dispose of normal
or malignant cells as seen in viral and autoimmune diseases and in the rare spontaneous
remissions of cancer. However, T cells are easily tolerized to self or tumor antigens and
"immune surveil┬Člance" has manifestly failed in every cancer that is clinically apparent.
It is the goal of this study to supply the specificities and affinities to patient T cells
without regard for their "endogenous" T cell receptor repertoire, directed by
antibody-defined recognition to kill malignant cells based on their expression of antigen.
We will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors
to yield "designer T cells" from normal patient cells. Prior studies in model systems
demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen
targets with IL2 secretion, cellular proliferation, and cytotoxicity, the hallmarks of an
effective, self-sustaining immune response. It therefore becomes of paramount interest to
extend these studies to a human system of widespread clinical relevance to explore the
clinical potential of this new technology. The target antigen for these studies is
carcinoembryonic antigen (CEA), which is prominently expressed on tumors of the stomach,
colon and rectum, breast, pancreas and other sites.


Inclusion Criteria:



- CEA expressing Gastric Cancer/GE Junction (>10ng/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

- No serious concomitant disease

Exclusion Criteria:

- Prior investigational treatment

- Requiring systemic steroids

- Serious medical conditions

- Concurrent malignancies

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Richard P Junghans, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roger Williams Hospital

Authority:

United States: Food and Drug Administration

Study ID:

3020-01A1

NCT ID:

NCT00429078

Start Date:

July 2007

Completion Date:

April 2011

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • T Cells
  • Gene Transfer
  • Stomach Neoplasms

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