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
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 weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.
• Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy
• Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein/microsatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial.
• Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Age ≥ 18 years
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration
• Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug.
• Adequate organ function within 14 days prior to registration, defined as the following:
‣ Absolute neutrophil count \>= 500/mm3
⁃ Absolute lymphocyte count \>= 400/mm3
⁃ Platelets \>= 75,000/mm3
⁃ Hemoglobin \>= 8 g/dL
⁃ Serum creatinine \< 2.0mg/dL or calculated/measured creatinine clearance \>= 50 ml/min
⁃ Bilirubin \<= 2 mg/dL
⁃ Aspartate transferase (AST) and Alanine transaminase (ALT) \<= 5.0 x upper limit of normal (ULN)
⁃ Alpha gal \< 0.35 IU/ml or negative
• Ability to provide informed consent and provision of written informed consent
⁃ Stated willingness to comply with all study procedures and availability for the duration of the study
⁃ Adequate cardiac function as defined as:
∙ No uncontrolled angina or severe ventricular arrhythmias
‣ No clinically significant pericardial disease
‣ No history of myocardial infarction (MI) in the last year before registration
‣ No Class 3 or higher New York Heart Association Congestive Heart Failure