FDA clears IND application for CAR-T to treat ALL
Click Here to Manage Email Alerts
The FDA has cleared an investigational new drug application for AUTO1, a chimeric antigen T-cell receptor therapy, for the treatment of adults with acute lymphoblastic leukemia, according to a press release from the agent’s manufacturer.
AUTO1 (Autolus Therapeutics) is an investigational, autologous, anti-CD19 CAR T-cell therapy with a fast target binding off-rate designed to minimize excessive immune system activation and associated cytokine release, according to the manufacturer.
FDA clearance of the IND application for AUTO1 means that Autolus can commence its phase 1 clinical trial (AUTO1-AL1) at centers in the United States. The first site for the AUTO1-AL1 study opened in the United Kingdom in March after the clinical trial application received approval from the U.K.’s Medicines and Healthcare products Regulatory Agency.
AUTO-1 also is being evaluated in a separate clinical trial for pediatric patients with ALL.
“We are looking forward to starting the treatment of patients at U.S. clinical study sites in an indication where currently no CAR-T therapy is approved," Christian Itin, PhD, chairman and CEO of Autolus, said in a company-issued press release. "Our AL1 clinical trial is already open in the U.K. and this milestone enables us to build on the encouraging data published to date, which suggests AUTO1 has a high level of clinical activity combined with a manageable safety profile."
The ongoing COVID-19 pandemic should have limited impact on the trial, according to Autolus, and the company continues to manufacture its cellular therapy products from its Cell and Gene Therapy Catapult in Stevenage, U.K., without interruption.
The AUTO1-AL1 study will enroll approximately 100 patients with relapsed or refractory ALL at 30 academic and nonacademic centers in the U.S., U.K. and Europe. The primary endpoint of the study is overall response rate, with secondary endpoints including duration of response and minimal residual disease-negative complete response rate.