Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429078
Status:
WITHDRAWN
Last Update Posted:
2012-03-02
First Post:
2007-01-30
Brief Title:
Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Phase I Trial of 2nd Generation Anti-CEA Designer T Cells in Gastric Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study proposes to determine the safety and tolerability of 2nd generation designer T cells in patients with gastric cancerDesigner T cells are prepared by removing white blood cells from the participant and then modifying these cells so that they recognize tumor antigenCEA These modified cells are then re infused back into the participant so that they can attack and kill tumor cellsEligibility 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 10ngml and be measurable radiologically or by physical exam
Detailed 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 surveillance 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None