Status:
RECRUITING
BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
Lead Sponsor:
Be Biopharma
Conditions:
Hemophilia B
Hemophilia B, Moderately Severe or Severe
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The BeCoMe-9 Study (BE-101-01) is a Phase 1/2, first in human, multi-center, open-label, dose-escalation study to evaluate the safety and clinical activity of a single intravenous (IV) dose of BE-101 ...
Detailed Description
The study includes 2 distinct parts: Part 1 and Part 2. In Part 1, an ascending-dose design will be utilized to enable evaluation of increasing doses in a stepwise manner. The objective for this dose ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06611436
Start Date
December 4 2024
End Date
July 1 2027
Last Update
October 20 2025
Active Locations (4)
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1
University of California, Davis
Davis, California, United States, 95616
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Washington Center for Bleeding Disorders
Seattle, Washington, United States, 98101