Clinical trialPhase 1 / Phase 2Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 6 November 2024
- Expected end
- June 2031
- Enrollment
- 23 participants
- Sites
- 1
- Primary outcomes
- Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)
- Sponsor
- Other
- Results posted
- No
- Last update
- 16 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.