"Chimeric Antigen Receptor T Cells: Clinical Development, FDA Approval, and What’s Coming Next"

Bruce Levine, Ph.D.
Barbara and Edward Netter Professor in Cancer Gene Therapy
University of Pennsylvania Perelman School of Medicine

Since the 1990’s, we have conducted clinical trials of gene modified T cells. 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 multi-center clinical trials and recently received FDA approval (KymriahTM, Novartis) in relapsed/refractory acute lymphoid leukemia in children and young adults. CAR T cells targeting new targets in hematologic malignancies and in solid tumors are underway and provide demonstration that it is possible to design immunity at will for therapeutic application.