EGFR BATs for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This protocol will confirm toxicities and estimate the clinical efficacy of combining anti-CD3 x anti-EGFR bispecific antibody (EGFRBi) armed activated T cells (EGFR BATs) given to patients with locally advanced or metastatic pancreatic cancer who have received at least one dose of first line chemotherapy and may have responding, stable or progressive disease. Phase Ib will confirm a safe dose of 8 infusions, given twice weekly, of EGFR-BATs in 3 to 6 subjects. The phase II portion of the trial will test the clinical efficacy of this dose in 22 patients (including those in Phase Ib).
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before starting the trial. It's best to discuss your specific medications with the trial team.
What is the safety profile of EGFR-targeting treatments in humans?
EGFR-targeting treatments, like erlotinib, have been used in lung and pancreatic cancer and are generally well tolerated, but they can cause side effects such as diarrhea, skin issues, and fatigue. Serious side effects, though rare, can include lung problems and infections, so it's important for doctors to monitor and manage these risks.12345
How does the EGFR BATs treatment differ from other treatments for pancreatic cancer?
The EGFR BATs treatment is unique because it uses a patient's own T cells, which are modified to target cancer cells by arming them with a bispecific antibody that recognizes EGFR, a protein often overexpressed in pancreatic cancer. This approach aims to enhance the body's immune response against the cancer, potentially improving survival rates compared to traditional chemotherapy or targeted therapies like erlotinib.678910
What data supports the effectiveness of the drug EGFR BATs for pancreatic cancer?
Research shows that adding EGFR-targeted drugs like erlotinib to chemotherapy in pancreatic cancer has shown some benefit, but the overall improvement in survival is marginal. In some cases, patients with specific genetic mutations in their tumors have responded exceptionally well to EGFR-targeted therapy.911121314
Who Is on the Research Team?
Tri Le, MD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
Adults with pancreatic adenocarcinoma who've had at least one chemo treatment can join this trial. They should have a life expectancy of over 3 months, be in good physical condition, and not planning to get pregnant or father a child. People with serious health issues, recent surgeries, active infections, certain drug treatments within the last few weeks or other cancers in the past 5 years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and T-cell Activation
White blood cells are collected and T-cells are activated and armed with bispecific antibodies
Bridging Chemotherapy
Participants receive one dose of chemotherapy prior to EGFR BATs infusion
Treatment
Participants receive EGFR BATs infusions twice weekly or weekly for a total of 8 or 4 infusions respectively
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EGFR BATs
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor