Gilead Sciences (GILD) said Friday its Kite unit has formed a partnership with Humanigen to study lenzilumab, an investigational anti-GM-CSF monoclonal antibody, in combination with Yescarta, in patients with relapsed or refractory diffuse large B-cell lymphoma.
The partnership will conduct a phase 1/2 study of lenzilumab with Yescarta. Kite will act as the sponsor for the study and will be responsible for its conduct.
Yescarta was the first CAR T cell therapy to be approved by the Food and Drug Administration for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Lenzilumab, alone or in combination with other therapies, is investigational and has not been approved by the FDA or any regulatory authority for any use.
GM-CSF has been identified as a potential key signal in the inflammatory cascade triggering toxicities associated with chimeric antigen receptor T (CAR T) cell therapy. Toxicities associated with CAR T therapy include neurologic toxicity and cytokine release syndrome.