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Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) 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 Sjögren'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.
Posted In: CGEM
