Dr. Neelapu on ZUMA-1 Trial Design of KTE-C19

Sattva S. Neelapu, MD, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the design of the ZUMA-1 trial of the chimeric antigen receptor (CAR) T-cell therapy KTE-C19 for patients with aggressive lymphomas.

ZUMA-1 is the first pivotal multicenter trial of the anti-CD19 CAR T-cell therapy KTE-C19 in patients with refractory, aggressive B-cell non-Hodgkin lymphoma. KTE-C19 is a genetically engineered T cell product that is trained to recognize the CD19 that is expressed on the surface of the tumor cells, Neelapu explains.

Once the patients had been screened and enrolled, they underwent a leukapheresis procedure to collect their T cells. Once the therapy was manufactured, they received conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days on days -5 to days -3. On day 0, they received the target dose of KTE-C19 at a dose of 2 million cells per kilogram. Following the infusion, patients were observed in the hospital for at least 7 days to manage side effects. The first tumor assessment was done at 30 days, Neelapu adds.