University of Maryland Greenebaum Comprehensive Cancer Center Expands CAR T-Cell Treatment Options

Now Certified to Offer Customized Gene Therapy Kymriah for Lymphoma and Leukemia

The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is expanding its CAR T-cell therapy options, having recently been approved to offer the gene therapy Kymriah to eligible lymphoma and leukemia patients.

Chimeric antigen receptor (CAR) T-cell therapy utilizes patients' own genetically engineered immune cells to recognize and attack the cancer. UMGCCC was certified in May to provide Novartis' CAR-T cell therapy, Kymriah, to adult patients with non-Hodgkin lymphoma as well as adolescents and young adults with B-cell acute lymphoblastic leukemia, or B-cell ALL.

In the last year, doctors at UMGCCC have used another CAR T-cell therapy, Yescarta, made by Kite-Gilead, to treat patients with types of large B-cell lymphoma who have received two or more therapies that had failed. They have treated 48 patients with this U.S. Food and Drug Administration (FDA)-approved therapy since March 2018. An additional 11 patients have received CAR T-cell therapy as part of clinical trials, bringing the total number of patients treated at UMGCCC with this therapy to 59.

"This groundbreaking new therapy has enabled us to help patients with few remaining treatment options," says Aaron P. Rapoport, MD, the Gary Jobson Professor in Medical Oncology at the University of Maryland School of Medicine (UMSOM) and a hematologist-oncologist who directs the Blood and Marrow Transplant Program at UMGCCC. "It's incredibly rewarding to see people who had failed multiple treatments now have their cancer in remission."

Fifty-four percent of the patients treated with CAR T-cell therapy at UMGCCC had a complete response to the treatment – the same response rate seen in a previous multi-center clinical study.

"It was my last resort. It was the only chance I had to save my life," says Charles C. "Chip" Baldwin, Jr., of Owings Mills, Md., whose cancer is now in remission after receiving CAR T-cell therapy in April 2018. Gary Gardiner, Jr., of Fredericksburg, Va., who was treated in May 2018 and remains cancer-free, says, "It's a true miracle. CAR T-cell therapy literally saved my life." Read about his cancer journey.

UMGCCC is one of a select few centers in the country to be accredited by FACT (the Foundation for the Accreditation of Cellular Therapy) for CAR T-cell therapy and other forms of cellular immunotherapy in addition to blood and marrow transplant. It is also participating in a Kite-Gilead research consortium of academic centers evaluating doctors' "real world" experiences in treating patients with this therapy.

The cancer center plans to open a clinical trial in the coming months that would make another CAR T-cell therapy – bb2121, which is produced by Celgene – available to patients with multiple myeloma, a cancer of the plasma cells in the blood.

Researchers now also have the ability to genetically engineer T-cells and create other immunotherapies at the new Fannie Angelos Cellular Therapeutics Laboratory at UMSOM.

"I'm pleased by the efforts underway to begin a clinical trial using a new universal CAR T-cell therapy that will be produced in the Fannie Angelos Cellular Therapeutics Laboratory,” says UMSOM Dean E. Albert Reece, MD, PhD, MBA, executive vice president for medical affairs at the University of Maryland, Baltimore, the John Z. and Akiko K. Bowers Distinguished Professor. "This laboratory has the potential to yield new lifesaving therapeutics, not only for cancer patients but for those with other life-threatening conditions."

The customized therapies involve removing immune cells, or T cells, from the patient and shipping them to a laboratory, where they are genetically modified to produce receptors on their surface called chimeric antigen receptors, or CARs. The receptors enable the T cells to recognize a protein on the surface of the patient's cancer cells. The modified cells are infused back into the patient, where they increase rapidly, and seek out and destroy the cancer cells.

The FDA approved Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) in 2017.

The treatment can cause serious side effects, including neurological problems and a life-threatening condition known as cytokine release syndrome (CRS), a systemic inflammatory response that causes high fever and flu-like symptoms. Cancer centers must be specially certified to offer the therapy.

"We have a highly skilled team of nurses and doctors, including oncologists, critical care specialists, cardiologists and pulmonologists, to care for our CAR T-cell therapy patients as well as our stem cell transplant patients. We also have talented support staff, including our apheresis and cell processing team, financial coordinators and social workers," says Kathleen Ruehle, RN, program manager and senior BMT coordinator.

UMGCCC's CAR T-cell program is part of a robust hematologic malignancies research and treatment program, caring for patients with various types of blood cancers, such as leukemia, lymphoma and multiple myeloma. Dr. Rapoport, who co-leads the cancer center's immunology and immunotherapy research program, is nationally recognized for his research on using engineered T cells to treat blood cancers.

About the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is a National Cancer Institute-designated Comprehensive Cancer Center in Baltimore. The center is a joint entity of the University of Maryland Medical Center and University of Maryland School of Medicine. It offers a multidisciplinary approach to treating all types of cancer and has an active cancer research program. It is ranked among the top cancer programs in the nation by U.S. News & World Report. www.umgccc.org.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine (UMSOM) was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world—with 43 academic departments, centers, institutes, and programs and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences and a distinguished recipient of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1 billion, UMSOM works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic, and clinically-based care for more than 1.2 million patients each year. UMSOM faculty, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit www.medschool.umaryland.edu.