The first lung cancer patient to be treated with a new type of immunotherapy involving the re-engineering of a patient's T cells, known as TCR T-cell therapy, took place at Winship Cancer Institute of Emory University (Winship) on May 7, 2020. The Winship patient is enrolled on a clinical trial evaluating the safety and tolerability of a TCR T-cell therapy product in patients with lung cancer.
Engineered T-cell receptor (TCR) therapy is one type of adoptive T-cell therapy that genetically modifies natural T cells in order to treat cancer. The other, chimeric antigen receptor (CAR) T-cell therapy, has gone through extensive testing for patients with hematological cancers, such as leukemia and lymphoma, and such patients are now being treated with CAR T-cell therapies. This particular TCR T-cell therapy targets a fragment of a tumor-specific protein called NY-ESO expressed on the surface of cancer cells of patients with a specific HLA allele. This is the first time that this product, targeted specifically to NY-ESO-1, is being clinically tested in patients with lung cancer. The Winship patient is a 49-year-old Georgia man with advanced non-small cell lung cancer.
The on-going trial is being run at several institutions around the world as a Phase Ib/IIa Pilot Randomized Study. Taofeek Owonikoko, MD, PhD, co-leader of Winship's Discovery and Developmental Therapeutics Program, is principal investigator for the trial in Georgia, and Winship is the only location in Georgia enrolling patients on this trial.
"CAR T-cell therapy has provided long-lasting remission for some lymphoma patients, and we hope to observe a similar benefit for lung cancer patients with this TCR T-cell therapy," says Owonikoko. "Conducting this trial at Winship requires strong collaboration among our experts in lung cancer, cellular therapy, and immunology."
The T-cell receptor (TCR) is a special receptor designed to bind to certain protein fragments on cancer cells. During treatment, a patient's white blood cells are removed from the body and genetically changed with these special receptors that enable the T cells to recognize and kill cancerous cells. The re-engineered cells are then infused back into the patient.
The primary objective of the study is to evaluate the safety and tolerability of the TCR T-cell process with genetically modified T-cells alone, or in combination with pembrolizumab, an immunotherapy drug that works by blocking the checkpoint inhibitor known as PD-1.
"Testing such a promising immunotherapy approach among lung cancer patients is a true milestone and demonstrates Winship's leadership in immunotherapy clinical trials," says Winship Executive Director Walter J. Curran, Jr., MD, the Lawrence W. Davis Chair in Radiation Oncology and the Georgia Research Alliance Eminent Scholar and Chair in Cancer Research. "I am particularly proud of our team's ability to initiate this work and move this research forward during the COVID pandemic."
The study, which is still enrolling patients, is expected to be completed by July 2, 2021.