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

NCT06479239 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HSR231503
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatic Cancer; Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)

  As defined in the protocol

  Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))

Secondary Outcomes (6)

• Overall Response Rate

  Through the dose escalation phase (during the first 8 infusions only, about 4 weeks after starting study treatment))

• Progression free survival

  Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)

• Overall Survival

  Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)

• Specific cytotoxicity by PBMCs against pancreatic cancer cell lines

  Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment

• Development of antibodies to pancreatic cancer antigens

  Before study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment

Study Arms (1)

EGFR Fresh Peripheral Blood Mononuclear Cells

EXPERIMENTAL

Participants will undergo apheresis to collect cells to make EGFR fresh peripheral blood mononuclear cells (FPBMC). These cells will be activated in the lab to fight against pancreas cancer. About 3-4 days after apheresis, participants will start receiving infusions of EGFR FPBMC. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression. Participants that have disease progression after the first 8 infusions may receive chemotherapy and then continue study treatment with the other 8 infusions.

Drug: EGFR FPBMC

Interventions

EGFR FPBMC DRUG

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

EGFR Fresh Peripheral Blood Mononuclear Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Known hypersensitivity to cetuximab
• Treatment with investigational agent within 3 weeks prior to registration
• Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration
• Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed)
• Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration
• History of a myocardial infarction within 1 year prior to registration
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed)
• History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• Females must not be currently breast feeding.
• The treating investigator feels the patient is not able to be compliant.
• History of active Bacillus Tuberculosis (TB).
• Has received a live vaccine within 30 days of registration.
• Prisoners or patients who are incarcerated.
• Patients who are compulsorily detained for treatment of a psychiatric or physical illness.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Tri Le, MD, DSc

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Donihee

CONTACT

434-243-6377; zwz6jm@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 28, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)