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NCT06611436 · ClinicalTrials.gov registry record · Phase 1
BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B
A Phase 1 study of Hemophilia B and Hemophilia B, Moderately Severe or Severe, sponsored by Be Biopharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT06611436: Recruiting Phase 1 study of Hemophilia B and Hemophilia B, Moderately Severe or Severe, sponsored by Be Biopharma.
NCT06611436 is a Phase 1 study of Hemophilia B and Hemophilia B, Moderately Severe or Severe that is actively recruiting participants, run by Be Biopharma. The registered enrollment target is 24 participants, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (75% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06611436, a Phase 1 study of Hemophilia B and Hemophilia B, Moderately Severe or Severe, is actively recruiting participants, sponsored by Be Biopharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study 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 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.
Primary Outcome
Incidence of AEs and SAEs
Conditions Studied
Interventions
- DRUG BE-101
Study Locations (4)
California
- University of California, Davis - Davis
Michigan
- University of Michigan - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
Washington
- Washington Center for Bleeding Disorders - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-12-04 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06611436 shows while recruiting
NCT06611436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 95-participant average among 20 other Hemophilia B trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Hemophilia B appearing as the primary indexed condition, and to 1 intervention - of which BE-101 is the first listed.
NCT06611436 reports a single indexed study location in California, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06611436 about?
NCT06611436 is a clinical study titled "BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B". 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...
What is the current status of trial NCT06611436?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-12-04. Estimated completion is 2027-07.
What conditions does trial NCT06611436 study?
This clinical trial studies the following conditions: Hemophilia B, Hemophilia B, Moderately Severe or Severe.
What interventions are being tested in trial NCT06611436?
The interventions under investigation include: BE-101 (DRUG).
Who is sponsoring clinical trial NCT06611436?
This trial is sponsored by Be Biopharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06611436 being conducted?
This trial has 4 study locations across California, Michigan, Minnesota, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06611436's enrollment target sits among peer trials
24 14th of 20 higher than 7 of 20 other Hemophilia B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hemophilia B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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