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CAR T-cell Therapy

CAR T Cell Immunotherapy for Pancreatic Cancer

Phase 1
Recruiting
Led By Mark O'Hara, MD
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 cytologically-proven ascites or known peritoneal disease on radiologic imaging for Cohort 2
Failure of at least one prior standard of care chemotherapy for advanced stage disease for Cohorts 1 - 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment on patients with pancreatic cancer that has spread or can't be removed with surgery.

Who is the study for?
This trial is for adults over 18 with advanced pancreatic cancer that can't be surgically removed or has spread, and who have already tried at least one chemotherapy. They must have a certain level of health and organ function, not have other active cancers or infections like HIV or hepatitis, no recent immunosuppressants use, and agree to birth control methods.Check my eligibility
What is being tested?
The study tests the safety of huCART-meso cells delivered either through the veins or directly into the tumor in patients with pancreatic cancer. It's an early-phase trial (Phase I) focusing on whether this method is safe and doable.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever, fatigue, drop in blood pressure; possible organ inflammation; allergy-like symptoms due to cell infusion; and complications from underlying bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have fluid in my abdomen or disease on my peritoneum confirmed by tests.
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I have tried at least one standard chemotherapy for my advanced disease.
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My advanced disease has not worsened on first-line chemotherapy.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have inoperable or spread pancreatic cancer.
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My cancer has spread to my liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of study subjects with treatment-related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Secondary outcome measures
Objective response rate
Overall survival (OS)
Progression-free survival (PFS)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 4 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion)Experimental Treatment1 Intervention
Subjects will receive a single dose of of 1-3x10^7 cells/m^2 lentiviral transduced huCART-meso cells on day 0 following a minimum 1 week washout from standard care chemotherapy. This initial intrahepatic infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart.
Group II: Cohort 3 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion)Experimental Treatment1 Intervention
Permanently closed
Group III: Cohort 2 - huCART meso cells via intraperitoneal infusion (IP)Experimental Treatment1 Intervention
Permanently closed
Group IV: Cohort 1: huCART-meso cells via intravenous infusion (IV).Experimental Treatment1 Intervention
Subjects will receive a single dose of 1-3x10^7/m^2 lentiviral transduced huCART-meso cells on day 0 via intravenous infusion.
Group V: Cohort -1: low dose huCART-meso cells via intravenous infusionExperimental Treatment1 Intervention
In the event that 2 DLTs occur among subjects enrolled in Cohort 1, then enrollment in Cohort 1 will be stopped and the dose will be de-escalated by 10-fold to 1-3x10^6 cells/m^2. Subjects will receive a single dose of 1-3x10^6 cells/m^2 lentiviral transduced huCART-meso cells on day 0.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,993 Previous Clinical Trials
42,875,545 Total Patients Enrolled
Mark O'Hara, MDPrincipal InvestigatorAssistant Professor of Medicine, Penn Medicine
3 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

huCART-meso cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03323944 — Phase 1
Pancreatic Cancer Research Study Groups: Cohort -1: low dose huCART-meso cells via intravenous infusion, Cohort 1: huCART-meso cells via intravenous infusion (IV)., Cohort 3 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion), Cohort 4 - huCART meso cells via intrahepatic infusion (hepatic arterial infusion), Cohort 2 - huCART meso cells via intraperitoneal infusion (IP)
Pancreatic Cancer Clinical Trial 2023: huCART-meso cells Highlights & Side Effects. Trial Name: NCT03323944 — Phase 1
huCART-meso cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03323944 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots available for enrollment in this experiment?

"Based on documentation hosted on clinicaltrials.gov, this scientific investigation is presently enrolling participants. This research project was initially advertised in September 2017 and the most recent update was from August 2022."

Answered by AI

Are there any risks associated with huCART-meso cell treatments?

"The potential risks associated with huCART-meso cells have been minimally assessed, leading our team at Power to rate its safety a 1 on the scale of 1–3."

Answered by AI

To what extent has recruitment for this research been completed?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical experiment is currently in need of participants and was initially posted on September 15th 2017. 18 volunteers are sought from 1 primary site."

Answered by AI
~1 spots leftby Sep 2024