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[TECHtalk] Genetically Engineered Immunity For Cancer: The Development and Global Regulatory Approvals of Chimeric Antigen Receptor (CAR) T Cells and What’s Coming Next

Bruce Levine
University of Pennsylvania, PA, USA


Since the 1990’s, we have conducted clinical trials of gene modified T cells. Gene editing has created T cell resistant to HIV infection. Chimeric antigen receptor (CAR) T cells targeting CD19 on B cells leukemias and lymphomas have induced durable complete responses in patients who are relapsed or refractory to all other available treatments. This synthetic biology technology has now undergone global multicenter clinical trials and recently received FDA, EMEA, Canada, Switzerland, Japan, and Australia approvals (KymriahTM, Novartis) in relapsed/refractory acute lymphoid leukemia in children and young adults as well as in diffuse large B cell lymphoma. Translation of these technologies from research bench to clinical application requires integrated scientific, engineering, clinical, and regulatory expertise. New designs for genetically engineered T cells include switches and potency enhancements that will be required for targeting solid tumors. The road forward for wide patient access to these uniquely personal cellular therapies depends not only on scientific progress in targeting, gene modification, and cellular manipulation, but also on meeting automation, engineering, clinical site onboarding, and health policy challenges.



Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, PA, USA. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 3000 cellular products administered to >1200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 26 issued US patents and co-author of >170 manuscripts and book chapters with a Google Scholar citation h-index of 82. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, serves as President Elect of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.



Host: Ramon Alemany - Cancer Virotherapy and Immunotherapy Group