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A novel cancer therapy studied and developed at the Medical College of Wisconsin (MCW) with promising clinical outcomes is leading to a larger phase II trial to improve on the current standard of care. Results of phase I of the first-in-the-world double targeted chimeric antigen receptor (CAR) T-cell therapy clinical trial were published in Nature Medicine.

This is a novel, cell-based treatment against cancer targeting two proteins (antigens CD19 and CD20) on the surface of cancer cells. This CAR-T cell therapy trial began in October 2017 and resulted in safe and promising outcomes for patients with relapsed and refractory B cell non-Hodgkin lymphomas which are cancers of the immune system. MCW researchers collected patients’ own immune cells (T-cells) and then used a specially engineered virus to augment their ability to identify and kill cancerous cells and effectively destroy the lymphoma. While phase I focused on safety and feasibility of the treatment, a multi-institutional phase II is being developed to determine the true efficacy and understand how the nuances of the treatment process can result in excellent outcomes for a larger subset of patients.

All patients in the clinical trial had failed prior treatments and their cancer had relapsed. Within 28 days of the CAR-T cell therapy, 82 percent responded positively. Six months later, more than half of the patients’ cancer remained in remission. A higher dose of the treatment correlated with a prolonged remission, a trend the researchers plan to study further in the trial’s second phase.

“Immuno-oncology using T-cell treatments shows incredible promise for cancer patients,” said Nirav Shah, MD, MSHP, principal investigator of the trial, associate professor of medicine in the division of Hematology and Oncology at MCW, and lymphoma and stem cell transplant specialist at the Froedtert & the Medical College of Wisconsin Clinical Cancer Center at Froedert Hospital. “This is a giant leap forward in personalized medicine. Very few cancer centers offer these novel combination of resources and high level of personalized medicine expertise. The encouraging results of this trial pave the way for more effective and efficient treatment options.”