CTL019: Phase I data

Data from 22 pediatric patients with relapsed or refractory ALL in an open-label, U.S. Phase I trial showed that CTL019 led to complete remission in 19 patients (86%). The first pediatric patient treated remains in remission after 20 months, while 5 pediatric patients have relapsed, including 1 patient who developed new tumor cells that do not express CD19. Additionally, all 5 evaluable adult patients with ALL in the trial achieved complete remission following treatment with CTL019. One adult patient subsequently underwent a bone marrow transplant and remains in remission, while 1 adult patient relapsed after 3 months with disease that also tested negative for CD19. No grade >2 infusion toxicities were reported, although 5 patients developed fevers within 24 hours of treatment and did not receive subsequent infusions of CTL019. Data were presented at the American Society of Hematology meeting in New Orleans. ...