NCT06479239 Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer
| NCT ID | NCT06479239 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Virginia |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 23 participants in total. It began in 2024-11-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 has 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.
Contact & Investigator
Tri Le, MD, DSc
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT06479239 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06479239 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06479239 currently recruiting?
Yes, NCT06479239 is actively recruiting participants. Contact the research team at zwz6jm@uvahealth.org for enrollment information.
Where is the NCT06479239 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT06479239 clinical trial?
NCT06479239 is sponsored by University of Virginia. The principal investigator is Tri Le, MD, DSc at University of Virginia. The trial plans to enroll 23 participants.
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