The European Medicines Agency (EMA) has approved Cullinan Therapeutics’ clinical trial application for CLN-978, a drug intended to treat rheumatoid arthritis (RA).
The Phase I open-label trial will focus on subjects with active, difficult-to-treat RA, adhering to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria.
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It aims to assess the therapy’s pharmacokinetics, pharmacodynamics and safety, as well as its impact on disease activity.
Sponsored by Cullinan Therapeutics, the trial is due to begin at Università Cattolica del Sacro Cuore in Italy and FAU Erlangen-Nuremberg in Germany.
CLN-978 is a cluster of differentiation 19 (CD19) × CD3 bispecific T cell engager designed to target B cells, including those with low CD19 levels.
The drug is intended to provide a subcutaneous delivery alternative for individuals with autoimmune conditions, including RA and systemic lupus erythematosus.
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By GlobalDataIt is currently being evaluated for the treatment of systemic lupus erythematosus in Europe, Australia and the US.
Cullinan Therapeutics chief medical officer Jeffrey Jones said: “We are pleased to announce the achievement of an important regulatory milestone allowing us to initiate a clinical trial of CLN-978 in RA in the second quarter of this year, with leading research institutions in Europe, as we simultaneously advance our systemic lupus erythematosus trial at sites around the globe.
“Delivering the potency of T-cell redirecting therapy with the potential for disease modification, CLN-978 offers off-the-shelf access and convenient subcutaneous dosing for improved accessibility and treatment flexibility for patients with a range of autoimmune diseases.”
Based in Massachusetts, US, Cullinan Therapeutics develops therapies designed to treat autoimmune diseases and cancer by inhibiting key disease drivers or helping the immune system to kill diseased cells.
Last year, the company announced positive topline data from a Phase I/II trial of its pipeline candidate zipalertinib following treatment with Rybrevant in patients with non-small cell lung cancer.
