Physicians and researchers from the Medical College of Wisconsin (MCW), Froedtert Hospital, Children's Hospital of Wisconsin, and BloodCenter of Wisconsin have successfully used a new immunology treatment developed by MCW researchers, chimeric antigen receptor (CAR) T-cell therapy, to extend the life of a 52-year-old Wisconsin man with lymphoma.

The new treatment genetically alters a person's immune system to uniquely personalize it to target cancer cells, a significant departure from more routine chemotherapy that attacks both healthy cells and cancer cells. The Froedtert & the MCW Clinical Cancer Center at Froedtert Hospital is offering this immunotherapy treatment option for patients who have certain non-Hodgkin lymphomas (B-cell). A pediatric clinical trial for CAR-T therapy treatment is expected to start later this year at Children's Hospital of Wisconsin.

"The CAR-T therapy clinical trial is a wonderful example of how Medical College of Wisconsin researchers rapidly translate basic science research into clinical applications," said Joseph E. Kerschner, MD, dean of the School of Medicine, provost and executive vice president at MCW. "MCW, along with our hospital partners at Froedtert and Children's, is unique in our region in having this expertise to bring these rapid advances in knowledge to change clinical care and the lives of our community in this fashion."

Bret C., 52, of Appleton, Wisconsin, is the first patient to participate in the phase I clinical trial. He was diagnosed with mantle cell lymphoma, a cancer of the immune system, in 2011, and despite chemotherapy, stem cell transplants, medications and other clinical trials, his cancer kept returning. He received the CAR-T cell dose in late October, and just six weeks later, his cancer was in full remission.

While CAR-T cell therapy has been under development since 2012, Bret was the first patient to participate in the first-ever clinical trial for a novel dual-targeted CAR-T cell against CD19 and CD20 antigens using the CliniMACS Prodigy device. The modified cells can identify cancer cells, attach to the cancer cells, and effectively destroy the cancer cells.

"Immuno oncology using T-cell treatments shows incredible promise for patients with cancer," said Parameswaran Hari, MD, MS. Dr. Hari is professor of medicine and chief of hematology and oncology and specializes in treating individuals with myeloma, leukemia and lymphoma at the Froedtert & MCW Clinical Cancer Center. "This is a giant leap forward in personalized medicine. Very few cancer centers anywhere offer the combination of resources and this high level of personalized medicine expertise. The encouraging results of the CAR-T cell trial positions us and our partners as a leader in clinical cancer care, and paves the way for more effective and efficient treatment options for patients."

"Bret's results from the CAR-T cell immunotherapy have been phenomenal," said Nirav Shah, MD, principal investigator of the trial and assistant professor of medicine (hematology and oncology) who specializes in lymphoma and stem cell transplant at Froedtert & MCW Clinical Cancer Center. Dr. Shah is a member of the Blood and Marrow Transplant (BMT) and Cellular Therapy team. "We are harnessing this knowledge from years of research and creating improved outcomes for patients. There is amazing potential here for the future of cancer treatment, and a healthier world is closer than ever."

The immunotherapy clinical trial continues as the research team tracks the progress of the second participant, who received a dose of CAR-T cells in December 2017. The third patient will begin treatment in February, with one new participant being dosed every six weeks.

Children's Hospital of Wisconsin, Froedtert and MCW recognized the potential of this treatment in 2014 and began acquiring the necessary equipment to prepare for a clinical trial. The CliniMACS Prodigy device enables the cancer team to conduct the CAR-T cell immunotherapy through a contained, cell-filtering desktop system that collects the patient’s own T-cells and augments them with cancer-fighting genes, producing new cells ready to be infused back into the bloodstream within 14 days. With the CliniMACS Prodigy system, the entire process is performed in a laboratory on the Froedtert & MCW academic medical center campus, saving precious time and money for the patient.

This critical equipment was made possible through philanthropic dollars raised by the Children's Hospital of Wisconsin Foundation together with the MACC Fund, Midwest Athletes Against Childhood Cancer, Inc. Additional philanthropic support for this study came from the Drive Fore a Cure Foundation, which was started by a long-term supporter of the MCW Cancer Center, Mr. Dennis Bush.

"This clinical trial demonstrates the strength of collaboration," said David Margolis, MD, professor of pediatrics (hematology and oncology). "The expertise of Medical College of Wisconsin researchers, the state-of-the-art facilities of Children's and Froedtert and the generosity of this community make this clinical trial possible. We look forward to starting a pediatric clinical trial for CAR-T treatment soon at Children's Hospital of Wisconsin in the MACC Fund Center."

The successful launch of this clinical trial is the result of years of collaborative cancer and cellular immunotherapy research at the BMT program. Pioneers in the field of immunotherapy, these researchers helped discover and develop how the body's own immune system has the power to fight cancer cells, leading to innovative ideas of alternatives to chemotherapy, radiation and transplants – traditional cancer treatments that are often effective in killing cancer cells but frequently damage the body's healthy cells. This knowledge paved the way for the CAR T-cell treatment, which trains the patient’s own immune cells to kill the cancer, rather than relying on foreign, toxic substances.

Patients who may be eligible for treatment through the CAR-T therapy clinical trial or other open trials – or physicians who would like to refer their patients – may call the BMT Program, (414) 805-0505.

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