Ignite Creation Date:
2024-07-17 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479239
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-17
Brief Title:
Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Phase III Study of Anti-CD3 x Anti-EGFR Bispecific Antibody EGFRBi Armed Fresh Peripheral Blood Mononuclear Cells EGFR FPBMC in Metastatic or Unresectable Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Panc 002
Brief Summary:
The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 CD3 x anti-Epidermal Growth Factor Receptor EGFR bispecific antibody fresh peripheral blood mononuclear cells EGFR FPBMC for patients with relapsed andor refractory pancreas cancer Participants receive 8 weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion
Detailed Description:
Once subjects are determined to be eligible white blood cells lymphocytes are collected via leukapheresis procedure The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are reinfused into the patients so the T cells can multiply and kill tumors
About 72 hours after the leukapheresis procedure EGFR FPBMC infusions will start After about 8-9 weeks participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses Before throughout and following EGFR FPBMC research blood will be collected to better understand immune response Disease status will be checked regularly during and after study treatment
About 72 hours after the leukapheresis procedure EGFR FPBMC infusions will start After about 8-9 weeks participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses Before throughout and following EGFR FPBMC research blood will be collected to better understand immune response Disease status will be checked regularly during and after study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None