Cullinan Therapeutics gains FDA clearance for CLN-978 to treat systemic lupus erythematosus
Summary: Cullinan Therapeutics has received U.S. FDA clearance for its Investigational New Drug application for CLN-978, a treatment for moderate to severe systemic lupus erythematosus (SLE). This marks the first FDA clearance for a CD19 T cell engager in autoimmune diseases.
The Phase 1 clinical trial will assess the safety and dosing of CLN-978 in patients who have not responded adequately to existing treatments. The trial will include a dose escalation phase and a dose expansion phase.
Previously, the company announced clearance to begin a global clinical trial in Australia. CLN-978 aims to provide a new therapeutic option for patients with SLE, which currently lacks effective long-term treatments.
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