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Clinical Trial Record

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

2024-11-06

2027-12

2031-06

23

Study Overview

Study of EGFRBi Armed Fresh PBMC 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 relapsed and/or refractory pancreas cancer. Participants receive 8 weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.

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.

  • Pancreas Cancer
  • Pancreatic Cancer
  • DRUG: EGFR FPBMC
  • HSR231503

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-06-17  

N/A  

2024-12-02  

2024-06-26  

N/A  

2024-12-05  

2024-06-28  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: EGFR Fresh Peripheral Blood Mononuclear Cells

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 receivin

DRUG: EGFR FPBMC

  • Participants will receive 8 weekly infusions of EGFR FPBMC, then 8 additional infusions every 2 weeks.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Dose limiting toxicities (DLTs) during the dose escalation phase (during the first 8 infusions only)As defined in the protocolThrough the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall Response RateNumber/Percentage of participants that have a partial or complete response to study treatmentThrough the dose escalation phase (during the first 8 infusions only, about 8 weeks after starting study treatment))
Progression free survivalTime from start of treatment to time of progression or death from any cause, whichever occurs first.Through 3 years after last infusion for each participant (a maximum of about 3 1/2 years)
Overall SurvivalTime from start of treatment to time of death from any cause.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 linesIn blood samplesBefore 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 antigensIn blood samplesBefore study treatment, about 8-9 weeks into study treatment, then 30-45 days, 6 months and 12 months after completion of study treatment
Survival of EGFR FPBMCs after multiple infusionsIn blood samplesPrior to study treatment, prior to each of the first 5 infusions, (optionally) about 1-2 days after each of the first 8 infusions, and about 8-10 weeks after starting study treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ashley Donihee

Phone Number: 434-243-6377

Email: zwz6jm@uvahealth.org

Study Contact Backup

Name: Sara Casana-Granell

Phone Number: 434-924-5254

Email: QNA7WG@uvahealth.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy 2. 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. 3. Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 5. Age ≥ 18 years 6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment/registration 7. 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. 8. 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" 9. Ability to provide informed consent and provision of written informed consent 10. Stated willingness to comply with all study procedures and availability for the duration of the study 11. 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

    • Exclusion Criteria:
    1. Known hypersensitivity to cetuximab 2. Treatment with investigational agent within 3 weeks prior to registration 3. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration 4. 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) 5. Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeks prior to registration 6. History of a myocardial infarction within 1 year prior to registration 7. 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 8. 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) 9. 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 10. Females must not be currently breast feeding. 11. The treating investigator feels the patient is not able to be compliant. 12. History of active Bacillus Tuberculosis (TB). 13. Has received a live vaccine within 30 days of registration. 14. Prisoners or patients who are incarcerated. 15. Patients who are compulsorily detained for treatment of a psychiatric or physical illness.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Tri Le, MD, DSc, University of Virginia

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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