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

Last updated: December 2, 2024
Sponsor: University of Virginia
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pancreatic Cancer

Pancreatic Disorders

Cancer

Treatment

EGFR FPBMC

Clinical Study ID

NCT06479239
HSR231503
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed locally advanced pancreatic cancer (LAPC)/unresectablepancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible forcurative 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 toenrollment on trial. Patients who qualify for immunotherapy due to mismatch repairprotein/microsatellite stable and tumor mutational burden status should also havereceived 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 daysprior to enrollment/registration

  7. Females of childbearing potential and males must agree to use an effective methodfor contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations duringstudy 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 thefollowing:

  • 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 >= 50ml/min

  • Bilirubin <= 2 mg/dL

  • Aspartate transferase (AST) and Alanine transaminase (ALT) <= 5.0 x upper limitof normal (ULN)

  • Alpha gal < 0.35 IU/ml or "negative"

  1. Ability to provide informed consent and provision of written informed consent

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. 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

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, openbiopsy, or significant traumatic injury within 28 days prior to registration

  4. Known active liver disease, human immunodeficiency virus (HIV)+ or evidence ofactive Hepatitis C or B virus; bleeding or condition associated with high-riskbleeding (anticoagulation is allowed)

  5. Active infection; prior antibiotic/antifungal/antiviral therapies within 2 weeksprior 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 treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

  8. Autoimmune disease that has required systemic treatment with chronic steroids orimmunosuppressive 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 thesubject 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 physicalillness.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: EGFR FPBMC
Phase: 1/2
Study Start date:
November 06, 2024
Estimated Completion Date:
June 30, 2031

Study 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.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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