A phase I gene therapy research study at UNC Lineberger is now recruiting patients with refractory pancreatic ductal adenocarcinoma (PDAC) to test the safety and tolerability of treating PDAC with escalating doses of autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen and containing the inducible caspase 9 safety switch (iC9.CAR.B7-H3 T-cells).
Here’s how it works: following a consultation, the study team will collect blood to create modified CAR T-cells using an eligible participant’s natural T-cells. Ideally, these CAR T cells will be more effective at killing cancer cells than normal cells. The researchers will conduct blood tests and other procedures to assess safety. If a patient is deemed able to participate, they will undergo pre-treatment for three to four days to prepare their body for introduction of the iC9.CAR.B7-H3 T-cells.
After receiving the modified cells, patients must stay near the hospital to be seen in clinic for frequent follow-up assessments including lab tests, imaging, and biopsies. Follow-up visits will be determined based on response to study treatment. Recommended phase 2 dosing will be determined based on maximum tolerability and other factors including participants’ ability to generate enough cells for infusion.
If you or someone you know might be eligible for and interested in this trial, you can contact the study’s coordinator Catherine Cheng by calling 919-445-4208 or sending an email. For information about other ongoing pancreatic cancer trials at UNC Lineberger, please visit the Clinical Trials section of our website.
—Tyler Rice, UNC Lineberger Pancreatic Cancer Center of Excellence