Investigational CAR-T therapy for Hodgkin lymphoma receives fast-track designation from FDA

Investigational CAR-T therapy for Hodgkin lymphoma receives fast-track designation from FDA

Based on proof-of-concept results from clinical trials at University of North Carolina Lineberger Comprehensive Cancer Center and Baylor College of Medicine, an investigational cellular immunotherapy for Hodgkin lymphoma has received a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration. Tessa Therapeutics announced the designation based on preliminary clinical trial results for a chimeric antigen receptor T-cell (CAR-T) therapy studied in patients with relapsed or refractory Hodgkin lymphoma at UNC and BCM. CAR-T therapy involves extracting specific immune cells from patients, engineering the cells in the lab to hunt tumor cells displaying a specific molecular target, and then re-infusing them back into the patient to fight their cancer. In addition to optimizing the therapy through early clinical trials, UNC Lineberger researchers played a critical role in early laboratory studies that led to the design of the investigational therapy. Tessa Therapeutics announced plans to continue developing the experimental treatment in phase II trials targeted for fourth quarter of this year. We started working on this therapy to improve outcomes for patients with relapsed or refractory Hodgkin lymphoma at a time when the prognosis for these patients was very poor, and the prolonged treatment was toxic, and impaired patients' quality of life. Clinical data from the clinical trial we have conducted at UNC indicate the investigational therapy is safe, and response rates were remarkable in a heavily pre-treated population." UNC Lineberger's Barbara Savoldo, MD, PhD, professor, UNC School of Medicine Division of Pediatric Hematology-Oncology Savoldois also the assistant director of the UNC Lineberger Clinical Immunotherapy Program. Under the direction of UNC Lineberger's Natalie Grover, MD, assistant professor of medicine and clinical director of the Cellular Therapy Program and UNC Lineberger's Anne Beaven, MD, associate professor of medicine and director of the Lymphoma Program, UNC Lineberger launched a phase 1b/2 clinical trial to study the safety of the CAR-T therapy for patients with relapsed or refractory Hodgkin lymphoma and for non-Hodgkin lymphoma positive for the CD30 cellular marker. BCM researchers independently launched trials of the investigational CAR-T therapy as well. UNC Lineberger recruited Savoldo and Gianpietro Dotti, MD, now a UNC Lineberger member and professor in the UNC School of Medicine Department of Microbiology and Immunology, from BCM in 2015 to continue their work developing and studying novel translational CAR-T therapies, including the CD30 CAR-T therapy for lymphoma. Related Stories



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