Your session is about to expire
← Back to Search
CAR T-cell Therapy
huCART-meso + VCN-01 for Pancreatic Cancer
Phase 1
Recruiting
Led By Janos L. Tanyi, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
Patients who have progressed or shown intolerance to at least one prior standard of care chemotherapy for advanced stage disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment (huCART-meso cells) to see if it is safe and works well with another cancer treatment (VCN-01).
Who is the study for?
This trial is for adults with specific advanced cancers: unresectable or metastatic pancreatic adenocarcinoma, and persistent or recurrent serous epithelial ovarian cancer. Participants must have tried at least one standard chemotherapy, be in good physical condition (ECOG 0-1), not need oxygen therapy, and have no other active invasive cancers or significant health issues like heart disease, autoimmune diseases requiring steroids, or certain infections.Check my eligibility
What is being tested?
The study tests a combination of huCART-meso cells and VCN-01 on patients with ovarian and pancreatic cancer using a '3+3 dose escalation' method to find the safest dose. This means small groups of patients receive increasing doses until doctors determine the highest dose that can be given safely.See study design
What are the potential side effects?
While specific side effects are not listed here, Phase I trials like this focus on safety and will monitor for any adverse reactions to the treatment combination. Side effects could range from mild reactions at injection sites to more serious immune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer cannot be removed by surgery and has spread.
Select...
My condition worsened or I couldn't tolerate the treatment after one standard chemotherapy.
Select...
My ovarian cancer is serous type and has come back or not gone away.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have minor breathing issues and my oxygen level is above 92% without assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of dose-limiting toxicities.
Type, frequency, severity, and attribution of AEs/SAEs as assessed by CTCAE v 5.0
Secondary outcome measures
Best Overall Response (BOR)
Duration of Response (DOR)
Overall Response Rate (ORR)
+3 moreTrial Design
3Treatment groups
Active Control
Group I: Cohort 2Active Control2 Interventions
Single dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.
Group II: Cohort -1Active Control2 Interventions
In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14.
Group III: Cohort 1Active Control2 Interventions
Single dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,197 Total Patients Enrolled
Theriva Biologics SLIndustry Sponsor
4 Previous Clinical Trials
166 Total Patients Enrolled
VCN Biosciences, S.L.Industry Sponsor
4 Previous Clinical Trials
166 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart fluid buildup or heart conditions that could affect the study.I have chronic hepatitis C with moderate to severe liver scarring.I am scheduled to receive high dose corticosteroids along with my treatment.I do not have any active cancer other than the one this study is targeting.My organs and bone marrow are functioning well.My pancreatic cancer cannot be removed by surgery and has spread.My cancer has spread to my brain.I currently have an infection.My condition worsened or I couldn't tolerate the treatment after one standard chemotherapy.I have an active hepatitis B or C infection.I have a history of Li Fraumeni syndrome or a genetic issue related to retinoblastoma.I have not taken PD-1 or PD-L1 inhibitors in the last 2 months.I have been diagnosed with cirrhosis.My ovarian cancer is serous type and has come back or not gone away.I am on strong medication for an autoimmune disease, similar to 10 mg of prednisone or more.I need extra oxygen.I am 18 years old or older.I do not have severe lung disease.You have a disease that can be measured using specific guidelines.I am fully active or restricted in physically strenuous activity but can do light work.I have minor breathing issues and my oxygen level is above 92% without assistance.Your heart is pumping blood effectively, as confirmed by a heart imaging test.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort -1
- Group 3: Cohort 1
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.
What severe side effects have been seen in Cohort 1?
"Cohort 1's safety is estimated to be a 1 because it is still in Phase 1, meaning that there isn't much data supporting how effective or safe the treatment is."
Answered by AI
Are patients currently being signed up for this clinical trial?
"The study, which was originally advertised on February 17th, is still looking for participants according to the information available on clinicaltrials.gov"
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger