UPDATE: FDA Grants Cullinan Therapeutics Clearance for Application to Investigate CLN-978 for the Treatment of Systemic Lupus Erythematosus, Phase I Trial to Begin Soon

The U.S. Food and Drug Administration (FDA) cleared the investigational new drug application for Cullinan Therapeutics’ CLN-978 for the treatment of systemic lupus erythematosus (SLE). Researchers will initiate a global Phase 1 trial to evaluate the safety of CLN-978 in people with active moderate to severe SLE. 

CLN-978 is an advanced, highly potent CD19 x CD3 bispecific T-cell engager designed to target and destroy harmful cells by binding to CD19 on B cells and CD3 on T cells. It is engineered to have a very high affinity for CD19, allowing it to effectively target B cells expressing very low CD19 levels in vitro (outside a living organism or in an artificial environment) and in-vivo (inside a living organism). The structure of CLN-978 includes two single-chain variable fragments: one binds strongly to the CD19 target on B cells, while the other binds to CD3 on T cells, helping direct the immune system to attack harmful cells. Additionally, CLN-978 has a single-domain antibody binding to human serum albumin (HSA, an abundant protein in human blood plasma, which may help extend CLN-978 time in the blood stream). CLN-978 is administered subcutaneously, and the design permits more patient-friendly dosing and potentially reduced toxicity. 

Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.

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