Cullinan Therapeutics announced that the European Medicines Agency (EMA) approved its Clinical Trial Application for CLN-978, a novel CD19xCD3 T cell engager. The Phase 1 trial will evaluate CLN-978 in patients with active rheumatoid arthritisarthritis in Europe, alongside an ongoing systemic lupus erythematosus trial. This marks a significant step for Cullinan, as CLN-978 is the only CD19-targeting T cell engager with both a U.S. FDA-cleared IND and a global regulatory development plan.
This EMA approval is crucial for advancing the development of a potentially transformative therapy for rheumatoid arthritis. Many patients with this chronic autoimmune disease either do not respond adequately to existing therapies or eventually develop resistance, leading to persistent pain, joint damage, and reduced quality of life. CLN-978 offers a novel mechanism of action with its high-affinity binding to CD19, aiming for more profound B cell depletion compared to current treatments. This could potentially lead to better disease control and improved outcomes for patients with refractory rheumatoid arthritis, a population with a high unmet medical need.
The Phase 1 trial is an open-label study designed to assess the safety, pharmacokinetics, pharmacodynamics, and impact of CLN-978 on disease activity in individuals meeting specific rheumatoid arthritis classification criteria. The study will take place at FAU Erlangen-Nuremberg, Germany, and Università Cattolica del Sacro Cuore, Rome, commencing in Q2 2025. CLN-978 is also under investigation for systemic lupus erythematosus in the U.S., Europe, and Australia. The drug is designed for subcutaneous administration, enhancing accessibility and treatment flexibility. Its small molecular size and inclusion of a single-domain antibody targeting human serum albumin contribute to an extended half-life.
The EMA approval paves the way for gathering clinical data on CLN-978 in a European patient population, which is vital for supporting potential future marketing authorization applications. Positive results from this trial could significantly impact the rheumatoid arthritis treatment landscape by offering a more effective and convenient therapeutic option. It could also validate Cullinan’s platform and accelerate the development of CLN-978 for other autoimmune diseases, strengthening the company’s position in the field of targeted immunotherapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
