Immunotherapy developer Affimed N.V. announced it has placed two trials for a T cell-engaging drug on clinical hold following three serious adverse events, including one patient death.
The trials were investigating AFM11 (Affimed) — a CD-19/CD-3-targeting T-cell engager — among patients with relapsed or refractory CD-19 positive B-cell non-Hodgkin lymphoma and acute lymphoblastic leukemia.
One death occurred in the ALL study and two life-threatening events occurred in the non-Hodgkin lymphoma study. The events occurred among patients enrolled in the highest-dose cohorts of each study.
Overall, investigators have treated 33 patients in the two phase 1 studies, with “preliminary signs of clinical activity observed in several patients,” according to the manufacturer.
The clinical hold does not affect Affimed’s other trials, including those investigating an agent that targets the NK cell receptor CD-16A.
The clinical stage biopharmaceutical company is working with global heath authorities, safety monitoring committees and the clinical investigators to review the events and data to determine next steps.