UNC Lineberger Comprehensive Cancer Center and Baylor College of Medicine in Houston have completed an early phase clinical trial showcasing the successful use of CAR-T therapy to treat Hodgkin lymphoma successfully for the first time. A powerful immuno-oncology approach that uses a patient’s reprogrammed immune cells, the results have been peer reviewed and published in the Journal of Clinical Oncology.
The Condition and the Breakthrough
Relapsed Hodgkin lymphoma patients often don’t respond well to other therapies, reported Barbara Savoldo, MD, PhD, professor in the UNC Department of Microbiology and Immunology at the UNC School of Medicine. Dr. Savoldo and team have been investigating the use of CAR-T cells targeting Hodgkin lymphoma in the past few years. Hodgkin lymphoma is a type of lymphoma in which cancer originates from a specific type of white blood cell called lymphocytes. Considered rare with less than 200,000 cases per year, according to the National Cancer Institute (NCI) an estimated 8,480 new cases will occur in 2020 with 970 deaths.
Approximately 85 percent of patients are either cured or can benefit from a significant overall survival after chemotherapy and radiation treatment. However, about 15 percent of patients don’t respond well or relapse and fit into the category called “refractory/relapsing.” Often there is little hope for these patients, hence why this study represents a breakthrough.
An immuno-oncology movement is in full force as researchers seek to capitalize and leverage breakthroughs of CAR-T cell therapies in new cancers. Now, researchers can now harvest human T cells from the patient and essentially genetically reengineer them to identify and recognize proteins in the cancer patient’s cells. Thereafter, the research team reinfuses this engineered immuno-oncology product back into cancer patient so that the product circulates throughout the blood system as a sort of alive agent that continuously battles the patient’s existing cancer cells. Sometimes the harvested and reengineered T cells can originate from the actual patient and in some cases the process can take T cells from other donors.
These CAR-T cell-based therapies have been approved by the U.S. Food and Drug Administration against blood cancers, such as acute lymphoblastic leukemia and diffuse large B-cell lymphoma. By targeting the CD19 protein attached to malignant cancerous cells, the immuno-oncology approach can increase success rates.
UNC and Baylor enrolled 41 patients to treat with an anti-CD30 CAR-T cell therapy including a pre-therapy regimen involving significant chemotherapy treatments before the actual administration of the CAR-T cell treatment. This pre-therapy regimen included the use of fludarabine. The treatment evidenced promise for the anti-CD30 CAR-T cell therapy against refectory/relapsing Hodgkin lymphoma.
The outcome: 59 percent (19) of those 32 patients struggling with active cancer receiving fludarabine for lymphodepletion as a pre-regimen prior to the CAR-T cells experienced a successful complete response. Patients deemed to have a complete response showed no evidence a year later of any new cancer. Of all the patients, 94 percent of the total survived post the study.
Barbara Savoldo, MD, PhD, professor in the UNC Department of Microbiology and Immunology
Note several other investigators/authors were involved in this study. Follow the link to learn more.