A novel cancer therapy studied and developed at the Medical College of Wisconsinhas advanced to a larger phase II clinical trial after showing promising results for patients in phase 1.
The phase I clinical trial of the double targeted chimeric antigen receptor (CAR) T-cell therapy – a process that involves genetically reprogramming a person’s immune system to target cancer cells in a personalized way – focused on the safety and feasibility of the treatment. Phase II will focus on determining the true efficacy of the treatment and understanding how the treatment process can result in “excellent outcomes” for a larger subset of patients, according to a MCW announcement.
While CAR-T cell therapy has been under development since 2012, the Froedtert & MCW Clinical Cancer Center was the first to treat patients using a specific dual-targeted gene therapy. The treatment involves collecting patients’ own immune cells and using a specially engineered virus to augment their ability to identify and kill cancerous cells and effectively destroy the lymphoma.
In the phase 1 clinical trial, 82% of patients responded positively within 28 days of the CAR-T cell therapy. Six months later, more than half of patients’ cancer remained in remission. All patients who participated in the clinical trial had failed prior treatments and their cancer had relapsed.
The results of the phase I clinical trial were published in the peer-reviewed Nature Medicine Monday.
The treatment represents a departure from what have become routine cancer treatments, such as transplants, chemotherapy and radiation therapy – methods that, while effective in killing cancer cells, also often damage healthy cells. Instead, the new treatment genetically alters a person’s own immune cells to target cancer cells in a unique and personalized fashion.
A 2018 BizTimes cover story told the story of the promising results experienced by one mantle cell lymphoma patient at Froedtert & MCW.
“Immuno-oncology using T-cell treatments shows incredible promise for cancer patients,” said Dr. Nirav Shah, principal investigator of the trial, associate professor at MCW, and lymphoma and stem cell transplant specialist at the Froedtert & MCW. “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.”
The cell product used for the treatment was manufactured using the CliniMACS Prodigy device, housed at the Froedtert & MCW Clinical Cancer Center at Froedtert Hospital.
Researchers with Froedtert & MCW’s Blood and Marrow Transplant and Cellular Therapy program have worked for years on the concept of harnessing the body’s own immune system to fight cancer cells, such as the CAR-T cell treatment, which trains the patient’s own immune cells to kill the cancer, rather than relying on foreign, toxic substances.
“We are harnessing knowledge from decades of research to improve outcomes for patients with lymphoma,” said Dr. Parameswaran Hari, senior author and professor and chief of the Division of Hematology and Oncology at MCW. “There is amazing potential here for the future of not just lymphoma patients but patients with many other cancers.”
[caption id="attachment_445267" align="aligncenter" width="350"] The Medical College of Wisconsin.[/caption]