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EGFR BATs for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Tri Le, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological proof of pancreatic adenocarcinoma with locally advanced or metastatic disease and received at least one dose of chemotherapy
ECOG Performance Status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging will be performed prior to treatment, 2 months after the last bats infusion, then according to standard of care for an average of 12 months
Awards & highlights
Study Summary
This trial will confirm if it is safe to give patients with pancreatic cancer a combination of two drugs, given in 8 infusions over 4 weeks. If Phase Ib is successful, the trial will then test the efficacy of this dose on 22 patients.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing EGFR BATs (a type of immune cell therapy) after standard chemotherapy for pancreatic cancer. Phase Ib will find a safe dose through 8 infusions twice weekly for up to 6 subjects. Phase II will assess how well this works in about 22 patients.See study design
What are the potential side effects?
Possible side effects may include reactions related to the immune system's activation such as fever and fatigue, potential organ inflammation due to T-cell engagement, and typical infusion-related responses like chills or shortness of breath.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have pancreatic cancer that has spread and received chemotherapy.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ imaging will be performed prior to treatment, 2 months after the last bats infusion, then according to standard of care for an average of 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging will be performed prior to treatment, 2 months after the last bats infusion, then according to standard of care for an average of 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall survival
Secondary outcome measures
Malignant Neoplasms
Clinical Efficacy
Examine tumor tissue for immune system cells, cytokines and proteins to estimate whether the type and number of immune cells correlates with clinical responses
Trial Design
1Treatment groups
Experimental Treatment
Group I: EGFR BATs after standard of care chemoExperimental Treatment1 Intervention
Subjects will undergo apheresis to collect peripheral blood mononuclear cells. Cells will be cultured for up to 2 weeks before activated T-cells will be harvested, armed with EGFR Biarmed activated T-cells, washed to remove unbound EGFRBi, and cryopreserved. Subjects will then receive one dose of standard of care chemotherapy prior to receiving EGFR BATs.
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,009 Total Patients Enrolled
Tri Le, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pancreatic cancer that has spread and received chemotherapy.You are expected to live for at least 3 more months.I am 18 years or older and can consent to my own medical treatment.I am willing to use effective birth control.I haven't had cancer treatments like chemo or radiation in the last 2 weeks.I am currently experiencing active bleeding or have a condition that could cause serious bleeding.I am currently on medication for an infection.I have not taken immunosuppressive drugs or steroids in the last 7 days.I haven't had any serious wounds, surgeries, or injuries in the last 28 days.I have an ongoing liver condition like cirrhosis or hepatitis.I am HIV positive or have active Hepatitis B or C.Your heart pumps blood properly at rest.I have had cancer other than my current one in the last 5 years.I do not have any serious health conditions that could worsen with this treatment.I have an active tuberculosis infection.I have not received a live vaccine in the last 30 days.I have been treated for an autoimmune disease in the last 2 years.I am currently breastfeeding.I am fully active or can carry out light work.I am a woman who can have children and I have a negative pregnancy test from the last 10 days.My liver, kidneys, and bone marrow are functioning well.I had a heart attack within the last year or earlier but still need medication for heart symptoms.You are allergic to cetuximab or other drugs like it that target the EGFR protein.
Research Study Groups:
This trial has the following groups:- Group 1: EGFR BATs after standard of care chemo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are involved in this experiment?
"The correct. The clinicaltrials.gov website contains information which suggests that this trial is looking for more participants. This trial was first posted on 7/28/2017 and updated as recently as 3/30/2022. They are searching for 22 individuals across 1 location."
Answered by AI
Are we still recruiting people for this clinical trial?
"Yes, this information is accurate according to the listing on clinicaltrials.gov. The study in question was first made available on 7/28/2017 and has been edited as recently as 3/30/2022. Presently, the trial is looking for 22 more patients from 1 location."
Answered by AI
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