Pharmaceutical manufacturer Affimed has halted two trials of its CD19/CD3-targeting T-cell engager AFM11 following reports of three serious adverse events (AEs), including one patient death. Across the two studies, a total of 33 patients had been treated.
The events occurred in two phase I trials investigating AFM11’s safety in patients with acute lymphocytic leukemia (ALL) or relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma (NHL). Of the three serious AEs, the patient death occurred in the ALL study while two life-threatening events occurred in the NHL study.
Affimed said that it is working with global health authorities, safety monitoring committees, and the clinical investigators to review the data and determine next steps for AFM11.