Third Fatality Exposed in China’s Gene Therapy Trials Amid Regulatory Overhaul
Endpoints News reports a third death in China’s investigator-initiated trials (IITs), involving a patient with an autoimmune disease treated with experimental CAR-T therapy. This follows two previously undisclosed fatalities in 2025: a six-year-old girl with a non-fatal neurodevelopmental disorder who died from an immune reaction to base-editing therapy, and a boy with Duchenne muscular dystrophy who died of respiratory distress after CRISPR treatment. While these incidents have triggered international scrutiny and led to the implementation of stricter regulations known as Order 818, industry experts argue that the IIT pathway remains valuable for rapid data generation. The new rules, effective May 2026, mandate rigorous preclinical testing and Good Manufacturing Practice compliance, though logistical delays and transparency concerns persist.