Cullinan Therapeutics has reached a significant milestone in autoimmune disease treatment development with the European Medicines Agency (EMA) approval to initiate a Phase 1 clinical trial for its investigational therapy CLN-978—a bispecific CD19-targeting T cell engager designed for subcutaneous administration.

This trial, set to begin in Q2 2025 at FAU Erlangen-Nuremberg (Germany) and Università Cattolica del Sacro Cuore (Rome), will focus on patients with active, treatment-resistant rheumatoid arthritis, as defined by the 2010 ACR/EULAR classification criteria. The study will assess safety, pharmacokinetics, pharmacodynamics, and its potential to reduce disease activity.

A New Direction in Autoimmune Disease Treatment

Unlike traditional therapies that broadly suppress the immune system, CLN-978 offers a novel mechanism of action. It redirects T cells to eliminate CD19-expressing B cells, which are key contributors to the autoimmune process. This off-the-shelf biologic also features convenient subcutaneous dosing, offering new flexibility in treatment access and delivery.

"CLN-978 is the only CD19-targeting T cell engager currently pursuing a global development strategy with FDA and EMA clearance," said Dr. Jeffrey Jones, Chief Medical Officer at Cullinan Therapeutics. "Its potential for disease modification could be a game-changer for patients who have limited treatment options."

CLN-978: A Broad Pipeline Across Autoimmune Indications

In addition to rheumatoid arthritis, CLN-978 is being evaluated in systemic lupus erythematosus (SLE) across sites in the U.S., Europe, and Australia. Its design—combining potency, precision, and administration ease—marks it as a promising new candidate in the growing field of next-generation immunotherapies for autoimmune disorders.

The Unmet Need in Rheumatoid Arthritis

Despite the availability of disease-modifying antirheumatic drugs (DMARDs), many patients with rheumatoid arthritis (RA) continue to experience disease flares, suboptimal responses, and impaired quality of life. An estimated 5.3 million adults live with RA across major global markets. Targeted immunotherapies like CLN-978 represent a potential step forward in precision medicine for these patients.

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Reference: The Manila Times