CAR T Cell Immunotherapy for Pancreatic Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic steroids, you may need to stop them at least 4 weeks before joining the trial.
What data supports the effectiveness of the treatment huCART-meso cells for pancreatic cancer?
Research shows that huCART-meso cells, which are engineered to target a protein called mesothelin found in pancreatic tumors, have been effective in animal studies by entering tumors and destroying cancer cells, nearly doubling survival times. In a small human trial, this treatment stabilized the disease in some patients and significantly reduced tumor activity in one patient, suggesting potential antitumor effects.12345
Is CAR T cell immunotherapy safe for humans?
Research shows that CAR T cell therapy targeting mesothelin in pancreatic cancer patients is generally safe, with no severe side effects like cytokine release syndrome (a severe immune reaction) or neurological symptoms reported. In studies, the treatment was well tolerated, and no dose-limiting toxicities (serious side effects that prevent increasing the dose) were observed.14567
How is the CAR T Cell Immunotherapy for Pancreatic Cancer treatment different from other treatments?
This treatment is unique because it uses genetically engineered T cells, called CAR T cells, to specifically target and attack cancer cells that express a protein called mesothelin, which is often found in pancreatic cancer. Unlike traditional treatments, this approach aims to harness the body's immune system to fight the cancer, offering a novel option for a condition with limited effective treatments.148910
What is the purpose of this trial?
Phase I study to establish the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma
Research Team
Mark O'Hara, MD
Principal Investigator
Assistant Professor of Medicine, Penn Medicine
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of lentiviral transduced huCART-meso cells via different delivery methods depending on cohort assignment
Safety Monitoring
Participants are monitored for dose-limiting toxicities (DLTs) and adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- huCART-meso cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor