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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00429078
• Other study ID #: 3020-01A1
• Status: Withdrawn
• Phase: Phase 1
• First received: January 30, 2007
• Last updated: March 1, 2012
• Start date: July 2007
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Roger Williams Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study proposes to determine the safety and tolerability of 2nd generation designer T cells in patients with gastric cancer.Designer T cells are prepared by removing white blood cells from the participant, and then modifying these cells so that they recognize tumor antigen(CEA). These modified cells are then re infused back into the participant so that they can attack and kill tumor cells.Eligibility for this study is diagnosis of carcinoma of the stomach with failure to respond to standard curative therapy. Tumors must express CEA as demonstrated by elevated serum CEA >10ng/ml and be measurable radiologically or by physical exam.

Description:

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¬lance" 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Genetic:
• 2nd Generation Designer T Cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roger Williams Medical Center