Inclusion Criteria:
* Adult Males (≥18) with moderately severe to severe Hemophilia B (FIX deficiency)
* Received ≥50 exposure days to Factor IX products preceding enrollment.
* Currently receiving prophylaxis treatment
* Adequate organ function and clinical labs
* Able to tolerate study procedures including leukapheresis.
Exclusion Criteria:
* Pre-existing or history of specific diseases
* B-Cell malignancy, EBV lymphoproliferative disease
* Primary immunodeficiency disease or disorder (PIDD) or systemic immuno-suppression
* Arterial and/or venous thromboembolic events within 2 years prior to dosing
* History of anaphylaxis or nephrotic syndrome
* Active infection (HIV, Hep B or C)
* History of inhibitor to FIX or inhibitor
* History of an allergic reaction or anaphylaxis to FIX products
* Planned surgical procedure within 6 months from BE-101 administration
* Previously dosed with gene therapy
* Participated in an interventional study and/or received an interventional study drug within 30 days or five-half-lives (whichever is longer) of consent into BeCoMe-9 and for the duration of the study
* Planned participation in clinical trial within one year after BE-101
* Administration of an investigational agent or vaccine within 28 days of leukapheresis and dosing of BE-101
Other protocol-defined inclusion/exclusion criteria may apply.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov