In the study of 55 patients, the drug achieved a major response rate of 61.8% and an overall response rate of 83.6%, with disease control in 98.2% of patients. Responses were durable, with a median duration of 17.8 months and median progression-free survival of 13.5 months. The treatment also performed well in high-risk patients, including those resistant to BTK inhibitors, where the major response rate reached 63.6%.
Participants had received at least two prior treatments, with a median of four, and were given four fixed-dose infusions. The safety profile was considered manageable. Low blood counts were common, but most other side effects were mild, and infections or bleeding occurred in fewer than 10% of patients.
With Breakthrough Therapy Designation granted in June 2025, these updated results support plans for regulatory submission, with a confirmatory trial expected as part of the accelerated approval pathway.