Autologous T cell therapy against CD19: Phase I data

Data from 20 patients ages 1-30 with relapsed or refractory ALL in an open-label, U.S. Phase I trial showed that a single infusion of KTE-C19 given after a conditioning regimen of chemotherapy (cyclophosphamide and fludarabine) led to 14 complete responses (<5% marrow blasts) and 12 minimal residual disease (MRD)-negative complete responses (<0.01% marrow blasts). Of the MRD-negative complete responders, 10 subsequently underwent hematopoietic stem cell transplantation (HSCT) and all 10 remained disease free at 10 months of follow-up. Grade 4 cytokine release syndrome occurred in 3 patients and the most common non-hematological grade 3 adverse events were fever, hypokalemia, fever and neutropenia and cytokine release syndrome. Data were published in The Lancet. NIH's NCI sponsored the trial. ...