Cullinan Therapeutics, Inc. announced on April 29, 2025, that it is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the United States. This marks the third autoimmune indication under development for CLN-978, following previous U.S. FDA IND clearance for systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval for rheumatoid arthritis (RA).
The trial will enroll patients with active, moderate to severe Sjögren's disease who meet 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 study's primary objective is to evaluate the safety and tolerability of CLN-978 in SjD patients, with secondary objectives including pharmacokinetics, pharmacodynamics, immunogenicity, and effect on disease activity.
The company expects to initiate this study in the second quarter of 2025. Sjögren's disease affects an estimated four million Americans and currently lacks treatments that comprehensively slow disease progression or address all aspects of the condition, highlighting the significant unmet medical need that CLN-978 aims to address with its differentiated CD19-targeting T cell engager approach.
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