UR Medicine Central Labs and UR Medicine Labs have been providing essential, behind-the-scenes services for sites across the U.S. participating in a clinical trial for cancer immunotherapy.
An Elmira man was featured in the local news because he was the first person enrolled at the Wilmot Cancer Institute to participate in the national clinical study of CAR T-cell therapy, which uses a patient’s own immune system to fight cancer. The trial is limited to people with certain types of lymphoma who have not responded to conventional treatment, and who meet strict eligibility criteria.
UR Medicine labs first partnered with a pharmaceutical company in 2015 to adapt and validate as assay for the presence and quantity of CAR19 T-cells in a patient’s blood, based on an a model developed by the National Cancer Institute. Since then the UR labs team has worked to refine and validate the assay for large-scale implementation.
The immunotherapy trial is designed to manipulate the body’s built-in defense mechanisms to fight cancer. Regular antibodies can be effective in fighting infection but are not so useful in killing tumor cells. Research has shown that a certain type of lymphocytes (a disease-fighting category of white blood cells) called T lymphocytes can target and kill lymphoma cells.
These "T-cells" must first receive permission from the body to fight, however. The patient's T-cells are introduced to DNA that first incorporates itself into their genome to produce a new protein – a chimeric antigen receptor (CAR) – that activates each cell, giving it the ability to detect and bind to a lymphoma cell.
"You're bypassing a lot of the regulatory checks and balances that have prevented previous attempts to generate tumor-killing T-cells," said Dr. Dan Ryan, director of Central Labs. "If (the cells) don't become activated, they die off."
Bill Crowe and Paul Rothberg from the Molecular Diagnostics Laboratory are leaders of the group that expanded the NCI test. Central Labs closely monitors test results from participating patient treatment sites across the U.S., and a vast network of lab professionals completes a series of time-sensitive steps.
Staff at Ridgeland Road assembles and sends out testing kits to each treatment site. The blood samples are then received via mail by Specimen Logistics staff six days a week. Technologists at the Tissue Typing Lab at Strong Memorial Hospital, Lymphoma/Leukemia Tissue Bank (SMH), Hematology Lab and Microarray Lab (Ridgeland) are responsible for processing and freezing all of the peripheral blood mononuclear cell blood tubes (PBMCs) for storage.
Phil Rock is a lab technician at SMH whose duties include tracking frozen samples for the CAR T-cell trial. He says the number of samples has skyrocketed since the trial began, which is a positive sign for immunotherapy.
"I think this trial, and the fact that (Central Labs) is growing is great for the department," said Rock. "I enjoy it immensely because having a hand in it allows me to use things that I went to school for and I've been trained to do that previously had no application."
Top: Clinical tech specialist, Jonathan Hoffmann, treats PBMC samples in the Human Leukocyte Antigen (HLA) Laboratory at URMC. Middle: Dr. Dan Ryan, director of UR Medicine Central Labs, which coordinates participation in clinical trials. Bottom: UR Medicine Central Labs kit production coordinator Deidra Davis, left, and Morgan Devaney.