NCT06611436TerminatedPhase 1/2
BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
BeCoMe-9: A Phase 1/2 Dose Escalation and Expansion Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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 in adults with moderately severe or severe Hemophilia B. Once infused, BE-101 is designed to engraft and continuously secrete FIX into the circulation to restore clinically meaningful levels of active FIX. BE-101 is an autologous (person's own cells) B Cell Medicine (BCM) which uses CRISPR/Cas9 gene editing to precisely insert human FIX gene into those cells.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 18 Sept 2024
- Start date
- 4 Dec 2024
- Primary completion date
- 29 May 2026
- Lead sponsor
- Be Biopharma
- Diseases
- Haemophilia
- NCT number
- NCT06611436
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
- 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.
Other illness
- History of inhibitor to FIX or inhibitor
- History of an allergic reaction or anaphylaxis to FIX products
Other
- Planned participation in clinical trial within one year after BE-101
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of California, Davis Coordinator of this site? Confirm its status | Davis | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Washington Center for Bleeding Disorders Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.