Cullinan Therapeutics, Inc. announced on April 16, 2025, that the European Medicines Agency (EMA) approved its Clinical Trial Application (CTA) for CLN-978. This approval allows the company to initiate a Phase 1 clinical trial in Europe to assess CLN-978 in patients with active, difficult-to-treat rheumatoid arthritis (RA).
The open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics, and effects of CLN-978 on disease activity. The trial is scheduled to begin in the second quarter of 2025 at leading research institutions in Germany and Italy, specifically FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome.
This regulatory milestone expands the global clinical development of CLN-978, which is already being studied in systemic lupus erythematosus (SLE) in the U.S., Europe, and Australia. CLN-978 is a CD19-targeting T cell engager designed for subcutaneous administration, offering potential for deeper B cell depletion and convenient off-the-shelf access for patients with autoimmune diseases.
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