A clinical trial to evaluate the long-term safety and durability of efficacy of BI 3720931, an inhaled lentiviral vector gene therapy, after single dose administration in a previous clinical trial in people with cystic fibrosis rolled-over from a previous clinical trial with BI 3720931 (LenticlairTM-ON).

Cystic fibrosis

Occurrence of treatment-emergent delayed AEs defined as new malignancies, new serious neurologic disorders, new serious rheumatologic or autoimmune disorders, new serious hematologic disorders, or new serious potentially product-related infections, until 15 years from enrolment

Time to loss of efficacy defined as the drop to below 5% (absolute) above baseline in forced expiratory volume in 1 second, percent of predicted value (FEV1pp), Time to first PEX from dosing, Occurrence of AEs up to 2 years after enrolment, Occurrence of serious adverse events (SAEs) throughout the study (up to 15 years), Occurrence of replication-competent lentivirus (RCL) throughout the study (up to 15 years)

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France, Italy, Netherlands, Spain