Milwaukee, Feb. 1, 2018 – 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, chimeric antigen receptor (CAR) T-cell therapy, to extend the life of a 52-year-old Wisconsin man.
Bret C., 52, of Appleton, Wis., is the first patient to participate in this novel clinical trial. He was diagnosed with mantle cell lymphoma, a cancer of the immune system, in 2011. Despite chemotherapy, stem cell transplants, medications and other clinical trials, his cancer kept returning. When presented with the dual-targeted CAR-T cell immunotherapy clinical trial option in late 2017, just weeks after a similar treatment had been approved by the FDA, Bret recognized it as the best opportunity to extend his life and agreed to participate. He received the CAR-T cell dose in late October, and just six weeks later, his cancer was no longer detectable in his body.
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.
While CAR-T cell therapy has been under development since 2012, the patient treated at Froedtert & the Medical College of Wisconsin Clinical Cancer Center is the first patient to participate in the first-ever, clinical trial for a novel dual-targeted CAR-T cell against CD19 and CD20 that were manufactured using the CliniMACS Prodigy® device, which is part of an automated CAR-T cell manufacturing platform developed by Miltenyi Biotec, a global company dedicated to enabling cellular and gene therapies. The modified cells can identify cancerous cells, attach to the cancer cells, and effectively destroy the cancer cells. A separate pediatric clinical trial for CAR-T treatment at Children’s Hospital of Wisconsin is expected to start later this year.
“Immuno-oncology using T-cell treatments shows incredible promise for patients with cancer,” said Parameswaran Hari, MD, MRCP, MS, professor and chief of the Division of Hematology and Oncology, specializing 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, MSHP, principal investigator of the trial, assistant professor of medicine in the division of Hematology and Oncology, specializing in lymphoma and stem cell transplant at Froedtert & MCW Clinical Cancer Center, and a member of the Blood and Marrow Transplant (BMT) program and Cellular Therapy team. “We are harnessing knowledge from decades of research to improve 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 this month, 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 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® device, the entire process is performed in a laboratory on the Froedtert & MCW academic medical center campus, saving precious time 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, Dennis Bush.
“This clinical trial demonstrates the strength of collaboration,” said David Margolis, MD, Children’s Hospital of Wisconsin, BMT program director and professor of Pediatrics in the division of Hematology and Oncology at MCW. “The expertise of Medical College of Wisconsin researchers, 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 separate pediatric clinical trial for CAR-T treatment soon at Children’s Hospital of Wisconsin in the MACC Fund Center.”
“We are extremely pleased to be collaborating with MCW for this first-in-human clinical trial with our dual-targeted CD19 and CD20 vector that is used to generate patient-specific CAR-T cells,” said Boro Dropulić, PhD, MBA, general manager and chief science officer of Lentigen Technology Inc., the company that developed and manufactures the vector used in the clinical trial, and which is also a subsidiary of Miltenyi Biotec. “The CliniMACS Prodigy® is a GMP compliant, automated cell manufacturing device developed by Miltenyi Biotec that robustly manufactures CAR-T cells from start to finish, making it possible in the future for hospitals to manufacture their own CAR-T cells for their patients.”
The successful launch of this clinical trial is the result of decades 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.
“BloodCenter of Wisconsin has long been a partner in the treatment of blood cancers in collaboration with Froedtert & the Medical College of Wisconsin and Children’s Hospital,” said BloodCenter of Wisconsin Executive Vice President of Research, Gilbert C. White, MD. “The basic research being performed at BloodCenter provides an important infrastructure for the development of this clinical trial, and we are thrilled to have contributed to what is a groundbreaking outcome for the patient.”
The Medical College of Wisconsin, Children’s Hospital of Wisconsin, Froedtert Hospital and BloodCenter of Wisconsin are working together toward a shared vision of better health. Bound by common missions of patient care, innovation, medical research and education and strengthened by the unique expertise each organization offers, the network leads the way in solving the world’s most pressing health concerns, creating healthier communities and saving lives.
Blood and Marrow Transplant Program
The Blood and Marrow Transplant program is a collaborative program between Children’s Hospital of Wisconsin, Froedtert Hospital and the Medical College of Wisconsin. The three independent organizations bring their own expertise to provide world-class medical care for several kinds of cancer, including leukemia, lymphoma and myeloma. The joint program has helped set the standard of care for transplant patents and are pioneers in vital research and clinical trials that continue to advance dynamic treatment options. Children’s Hospital of Wisconsin and Froedtert Hospital both have day hospital programs designed to improve patients’ quality of life during treatment by providing convenient and comfortable care settings. The Medical College of Wisconsin provides researchers, physicians, research facilities and advanced laboratories that are necessary to support state-of-the-art treatments. Since 1980, Froedtert has performed more blood and bone marrow transplants than any other center in Wisconsin, and has outperformed national averages for transplant survival outcomes for the last several years. Children’s Hospital of Wisconsin pediatric oncology program is nationally ranked by U.S. News and World Report.
Lentigen Technology, Inc. (LTI; Gaithersburg, MD, US) a leader in the design, construction and manufacture of lentiviral vectors for clinical application, is a subsidiary of Miltenyi Biotec GmbH, a pioneer in developing innovative workflows, tools, and technologies for clinical cell and gene therapy applications. Miltenyi Biotec is dedicated to support customers to move from translational research into the clinic, and towards commercialization with its comprehensive portfolio of high quality, GMP compliant, state-of-the-art platforms, and technologies. Miltenyi’s GMP manufacturing facilities in the U.S. and Germany meet both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) requirements for current Good Manufacturing Practices (cGMP). For more information about Miltenyi Biotec or Lentigen, please visit http://www.miltenyibiotec.com or www.lentigen.com.
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