BeCoMe-9: A Clinical Study of BE-101 for the Treatment of Adults With Moderately Severe or Severe Hemophilia B

Part of paid clinical trials in Davis, California.

Sponsor
Be Biopharma
Study ID
NCT06611436
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hemophilia B
  • Hemophilia B, Moderately Severe or Severe

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BE-101 — DRUG
    IV Infusion of BE-101 dose from Dose Level 1
  • BE-101 — DRUG
    IV Infusion of BE-101 dose from Dose Level 2
  • BE-101 — DRUG
    IV Infusion of BE-101 dose from Dose Level 3
  • BE-101 — DRUG
    IV Infusion of BE-101 with optimal dose selected from Part 1 Dose Escalation

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Dose Escalation, Dose Level 1
  • Experimental: Part 1 - Dose Escalation, Dose Level 2
  • Experimental: Part 1 - Dose Escalation, Dose Level 3
  • Experimental: Part 2 - Dose Expansion, Cohort 2a Adult Expansion, Optimal Dose Selected in Part 1 Dose Escalation

Primary Outcome Measure

Adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year post dose ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95616-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Washington Center for Bleeding DisordersSeattleWashington98101-

Find similar trials in Davis, CA

By research site
University of California, Davis· Davis, CAUniversity of Michigan· Ann Arbor, MIUniversity of Minnesota· Minneapolis, MNWashington Center for Bleeding Disorders· Seattle, WA

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