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CAR T-cell Therapy
Armed Activated T-Cells for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Kenneth Yu, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have metastatic pancreatic cancer and have received at least first-line chemotherapy
Histological or cytological proof of pancreatic adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective for people with advanced pancreatic cancer.
Who is the study for?
This trial is for adults with advanced pancreatic cancer who've had first-line chemo. They should have stable or progressing disease after treatment, good performance status (able to carry out daily activities), and adequate organ function. Pregnant women can't join, nor those breastfeeding or with certain medical conditions that could affect compliance.Check my eligibility
What is being tested?
The study tests EGFR-BATs (anti-EGFR-bispecific antibody armed activated T-cells) in patients to determine the safest dose and side effects. Participants must have previously received standard chemotherapy for their condition.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation, such as inflammation in various organs, infusion-related reactions, fatigue, increased risk of infection due to immune response alteration, and possible allergic reactions if sensitive to components like cetuximab.
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 first-line chemotherapy.
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My diagnosis is pancreatic cancer, confirmed by lab tests.
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I am of childbearing age and have a recent negative pregnancy test.
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I am mostly able to care for myself and perform daily activities.
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My kidney function is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate toxicity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pancreatic AdenocarcinomaExperimental Treatment1 Intervention
Participants have metastatic pancreatic cancer who have received at least first line chemotherapy and have disease progression during or within 6 months of treatment.
Find a Location
Who is running the clinical trial?
University of VirginiaOTHER
753 Previous Clinical Trials
1,245,024 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,615 Total Patients Enrolled
Kenneth Yu, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition that could worsen with this treatment.My diagnosis is pancreatic cancer, confirmed by lab tests.You are allergic to cetuximab or other similar drugs for EGFR.I have an ongoing liver condition like cirrhosis or hepatitis.Your body has enough white blood cells to fight off infections.I am not on steroids or immunosuppressants, except for certain medical conditions.I am HIV positive.Your disease can be measured and evaluated using specific criteria.I have no severe side effects from previous cancer treatments.I have brain metastasis causing symptoms.I haven't had any serious wounds, surgeries, or injuries in the last 28 days.I am of childbearing age and have a recent negative pregnancy test.Your total bilirubin level must be less than or equal to 2 mg/dl, but having a biliary stent is allowed.I have pancreatic cancer that has spread and received first-line chemotherapy.I am mostly able to care for myself and perform daily activities.I am currently being treated for an infection.You have a certain number of a type of white blood cells called lymphocytes.I have pancreatic cancer that has spread and was treated with chemotherapy.My cancer did not improve or got worse within 6 months after treatment with 5-FU or gemcitabine.I am 18 years or older and have given my consent.My kidney function is within the required range.I am willing to use effective birth control.Your SGPT and SGOT levels should be less than 5 times the normal range.Your platelet count is at least 75,000 per cubic millimeter.I do not have active bleeding or a condition that could cause serious bleeding.Your hemoglobin level is 8 grams per deciliter or higher.Your heart's pumping function is normal at rest.
Research Study Groups:
This trial has the following groups:- Group 1: Pancreatic Adenocarcinoma
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.
To what extent does utilization of an anti-EGFR-bispecific antibody armed activated T-cells pose a risk to subjects?
"The anti-EGFR bispecific antibody armed activated T cells have been assigned a score of 1, as this is an early Phase 1 trial which has only limited evidence to support its safety and efficacy."
Answered by AI
Is there an ongoing search for volunteers to participate in this research study?
"According to the material on clinicaltrials.gov, this trial is not actively seeking participants at present. Initially posted on October 17th 2019 and modified most recently on October 7th 2022, it does not have any available openings for enrolment; however there are still 757 other trials recruiting potential candidates right now."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Florida
California
Other
How old are they?
18 - 65
What site did they apply to?
University of Virginia (Specimen Analysis)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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