Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01723306
Status:
SUSPENDED
Last Update Posted:
2016-06-14
First Post:
2012-11-01
Brief Title:
Phase IIPilot Study of 2nd Generation Anti-CEA Designer T Cells in Adenocarcinomas
Sponsor:
Roger Williams Medical Center
Organization:
Roger Williams Medical Center
Study Overview
Official Title:
Phase IIPilot Study of 2nd Generation Anti-CEA Esigner T Cells in Adenocarcinomas
Status:
SUSPENDED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 remis-sions 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 these studies 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 This extends the approach of Anderson Rosenberg and co-workers to introduce or augment expression of genes in patients T cells in a therapeutic setting
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 predominantly expressed on tumors of the colon and rectum breast pancreas and other sites
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 predominantly expressed on tumors of the colon and rectum breast pancreas and other sites
Detailed Description:
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 tumors
The application of these therapies in the four Phase IIPilot 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 monitored
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 Cancers CEA-G
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Colorectal Cancers CEA-C
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Lung Cancers CEA-L
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Solid Tumors CEA-S
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
The application of these therapies in the four Phase IIPilot 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 monitored
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 Cancers CEA-G
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Colorectal Cancers CEA-C
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Lung Cancers CEA-L
A Phase II Pilot Study of Second Generation Anti CEA Designer T Cells in Solid Tumors CEA-S
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
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