Pre-clinical evidence and clinical data implicate GM-CSF as a crucial initiator in the systemic inflammatory pathway driving the serious and life-threatening chimeric antigen receptor T cell (CAR-T) associated cytokine release syndrome (CRS).
[6] A multi-center phase I/II trial including the MD Anderson Cancer Center will evaluate lenzilumab as prophylaxis for CRS and neurotoxicity in collaboration with Kite and is currently in recruitment.
[10] A Phase II study with the University of Zürich and the United Kingdom's Stem Cell Transplantation IMPACT group will be investigating the efficacy of lenzilumab in prevention of acute GVHD and is currently in active planning.
[11] In light of the recent coronavirus disease 2019 (COVID-19) pandemic, the role of GM-CSF in the cytokine-mediated immunopathology of lung injury and acute respiratory distress syndrome (ARDS) has been under investigation.
[citation needed] A Phase III protocol for evaluating the efficacy of lenzilumab in the prevention and treatment of ARDS has been submitted to the FDA.