Autologous CD19-targeted CAR-modified T cells infused as consolidative therapy to patients with high risk CLL with minimal residual disease following six cycles of chemotherapy.
Cyclophosphamide conditioning therapy used before infusing CAR+ T cells, which were given in 3 dose-escalating cohorts.
Six patients received CAR+ T cells, completing two dose cohorts of 3 x 106 and 1 x 107 CAR+ T cells/kg. No DLT observed. Cytokine release syndrome (CRS) observed in 2 patients and correlated with modified T cell persistence.
Two patients with PR following first-line chemotherapy achieved CR after T cell infusion; 2 patients maintained PR; and 2 progressed.