Autolus presents new data on T cell therapies in leukemia, lymphoma
Autolus Therapeutics announced new data highlighting progress on its next-generation programmed T cell therapies to treat patients with acute lymphoblastic leukemia and adults with relapsed/refractory diffuse large B cell lymphoma. Updated results for ALLCAR19, the Phase 1 trial evaluating AUTO1 in adults with recurrent/refractory ALL, were presented by Dr. Claire Roddie. The trial is designed to assess the primary endpoints of safety and feasibility of product generation, as well as other secondary endpoints, including efficacy. The trial enrolled patients with a high tumor burden, who were considered high-risk for experiencing cytokine release syndrome. Product was manufactured for 19 patients; product for 13 of those patients was manufactured using a semi-automated closed process, which will be used for commercial supply. As of the data cut-off date of November 25, 16 patients had received at least one dose of AUTO1. AUTO1 was well tolerated, with no patients experiencing Grade 3 or greater CRS, and 3 of 16 patients, who had high leukemia burden, experiencing Grade 3 neurotoxicity that resolved swiftly with steroids. Of 15 patients evaluable for efficacy, 13 achieved MRD negative CR at 1 month and all patients had ongoing CAR T cell persistence at last follow up. CD19-negative relapse occurred in 22% patients. In the patients dosed with AUTO1 manufactured in the closed process, 9 of 9 achieved MRD negative CR at 1 month and 6 months event free survival, and overall survival in this cohort was 100%.