Cullinan Therapeutics Wins EMA Approval To Launch CLN-978 Trial In Rheumatoid Arthritis

(RTTNews) - Cullinan Therapeutics, Inc. (CGEM) Wednesday announced that the European Medicines Agency has approved its Clinical Trial Application for CLN-978, enabling a Phase 1 trial in patients with treatment-resistant rheumatoid arthritis.

The open-label study will begin in Q2 2025 and focus on safety, pharmacokinetics, pharmacodynamics, and clinical activity.

CLN-978, a novel CD19xCD3 bispecific T cell engager, is designed to target B cells with high precision, even at low CD19 expression levels, offering subcutaneous dosing for improved accessibility. It is the only CD19-targeting T cell engager advancing globally with both EMA and U.S. FDA regulatory clearance.

Dr. Jeffrey Jones, CMO of Cullinan, emphasized the drug's potential for disease modification and treatment flexibility across autoimmune conditions. Lead investigator Dr. Ricardo Grieshaber-Bouyer noted the urgent need for new therapies in rheumatoid arthritis, where many patients fail to achieve sustained remission with current treatments.

Rheumatoid arthritis affects over 5 million people across major global markets. Despite the availability of DMARDs, a significant number of patients continue to face poor responses, ongoing symptoms, and diminished quality of life.

Wednesday, CGEM closed at $7.61, down 2.44%, and is currently unchanged in after-hours trading on the Nasdaq Global Select Market.