Hackensack Meridian John Theurer Cancer Center Treats its First Patient in Innovative Cell Therapy Clinical Trial

Researchers at Hackensack Meridian John Theurer Cancer Center — part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University —treated its first patient at the Center in a cutting-edge phase I clinical trial of LYL845, a novel cellular therapy under evaluation for advanced melanoma and other select solid tumors. A type of tumor-infiltrating lymphocyte (TIL) therapy, LYL845 is custom-made from a patient’s cells and designed to help the immune system find and kill cancer cells.

TIL therapy harnesses and expands the power of the patient’s immune cells that have already been fighting cancer, such as those in a patient whose cancer continues to grow despite checkpoint inhibitor immunotherapy. TILs are made from white blood cells (T cells or lymphocytes) that come from a piece of a patient's own tumor removed during surgery. The TILs are shipped to a state-of-the-art manufacturing center where they are modified and expanded to generate up to billions of cells; several weeks later, they are returned to the patient’s body, where they can detect and destroy remaining cancer cells.

"Clinical trials such as this one require a tremendous amount of preparation, detailed work, and integration across specialties and departments to be able to deliver excellent clinical care," said Martin Gutierrez, MD, director, Drug Discovery/Phase I Program at John Theurer Cancer Center, co-chief, Thoracic Oncology, and the study's principal investigator. "This makes Hackensack University Medical Center unique and an extraordinary place for clinical research."

The basis of LYL845 is epigenetic reprogramming designed to promote and preserve T-cell stemness — the ability of T cells to self-renew and maintain certain important qualities in fighting cancer. The study has two phases. The first includes patients ages 18-75 with metastatic or locally advanced melanoma, and the second includes non-small cell lung cancer, or colorectal cancer that has relapsed or persists despite prior therapy for advanced disease that may have included checkpoint inhibitors (such as nivolumab or pembrolizumab).

Patients who participate in the clinical trial undergo surgery to remove a small piece of their tumor that contains TIL. The TIL are shipped to a manufacturing center where they are reprogrammed and expanded from millions of cells to up to billions of cells, typically taking 4 to 6 weeks. The cells are then shipped back to the Center and patients are admitted for treatment with high-dose chemotherapy followed by an infusion of their TIL and high-dose interleukin-2 treatment. Patients are typically discharged from the hospital following an observation period.

"Personalized cellular therapies that boost the power of a patient's immune system to fight their own unique tumor cells hold great promise for managing advanced cancers that persist despite standard therapies," noted Andre Goy, MD, MS, chairman and executive director of John Theurer Cancer Center. "This clinical trial is a stellar example of the innovative therapeutic approaches we offer people with cancer who may have run out of other treatment options."

For more information about this study or to refer a patient, called 551-996-3986 or email suzanne.kosky@hmhn.org.