Progression of the study
The study will start with a 28-day baseline phase.The end of the study is defined as the date of the last follow-up visit performed by the last patient in the study.The planned follow-up treatment phase will be 24 months after the last dose of study treatment.The total duration of the study will be approximately 96 months, including about 48 months of active enrollment (24 months for phase I and 24 months for the expansion cohorts phase), 24 months of treatment, and 24 months of follow-up.