NCT06479239

Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer

Phase I/II 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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 metastatic or unresectable pancreas cancer. Participants receive 8 twice 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.

Conditions

• Pancreas Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	EGFR FPBMC	Participants will receive 8 twice weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.

Timeline

• Start date: 2024-11-06
• Primary completion: 2027-12-01
• Completion: 2031-06-01
• First posted: 2024-06-28
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study