Cullinan to initiate study of CLN-978 in patients with Sjogren’s disease

Cullinan Therapeutics (CGEM) announced that the Company is initiating a study of CLN-978 in patients with Sjogren’s disease in the U.S. The Company previously received U.S. Food and Drug Administration, FDA, Investigational New Drug, IND, Application clearance to study the CD19 T cell engager in patients with moderate to severe systemic lupus erythematosus, SLE, and European Medicines Agency, EMA, approval to study CLN-978 in active, difficult-to-treat rheumatoid arthritis. The trial will enroll patients with active, moderate to severe Sjogren’s disease who fulfill the 2016 American College of Rheumatology, ACR/European Alliance of Associations for Rheumatology, EULAR, classification criteria and are positive for anti-SSA/RO antibodies and/or rheumatoid factor. The dose escalation scheme will be similar to the SLE study. The primary objective of the study is to evaluate the safety and tolerability of CLN-978 in patients with SjD. Secondary objectives include pharmacokinetics, pharmacodynamics, immunogenicity, and effect on disease activity. The Company expects to initiate the study this quarter.