RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-06

Study Completion:2031-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06479239

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Ashley Donihee

CONTACT

434-243-6377

zwz6jm@uvahealth.org

Sara Casana-Granell

CONTACT

434-924-5254

QNA7WG@uvahealth.org

Principal Investigator

Tri Le, MD, DSc

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

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

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

Study Start Date2024-11-06

Study Completion Date2031-06

Study Record Updates

Study Start Date2024-11-06

Study Completion Date2031-06

Terms related to this study

Additional Relevant MeSH Terms

Pancreas Cancer
Pancreatic Cancer