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NCT05739643 · ClinicalTrials.gov registry record · Phase 1
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
A Phase 1 study of Krabbe Disease, sponsored by Forge Biologics.
- Active
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 3
- Study locations
NCT05739643 is a Phase 1 study of Krabbe Disease that is active but no longer recruiting, run by Forge Biologics. The registered enrollment target is 9 participants, below the 417-participant average among 4 other Krabbe Disease trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05739643, a Phase 1 study of Krabbe Disease, is active but no longer recruiting, sponsored by Forge Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a non-blinded, non-randomized dose escalation study of intravenous FBX-101 in which subjects will receive a single infusion of an adeno-associated virus gene therapy product, after more than 21 days of the HSCT (UCBT preferred HSCT source). Data from previously transplanted patients with infantile and late infantile Krabbe disease will be used as a comparator group.
Conditions Studied
Interventions
- BIOLOGICAL FBX-101
Study Locations (3)
California
- Children's Hospital of Orange County (CHOC) - Orange
Michigan
- University of Michigan Hospitals - Michigan Medicine - Ann Arbor
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-02-03 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05739643
The ClinicalTrials.gov registry entry for NCT05739643 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 417-participant average among 4 other Krabbe Disease trials with a reported enrollment target (98% lower). The listed sponsor is Forge Biologics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Krabbe Disease appearing as the primary indexed condition, and to 1 intervention - of which FBX-101 is the first listed.
NCT05739643 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05739643 about?
NCT05739643 is a clinical study titled "Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT". This is a non-blinded, non-randomized dose escalation study of intravenous FBX-101 in which subjects will receive a single infusion of an adeno-associated virus gene therapy product, after more than 21 days of the HSCT (UCBT preferred HSCT source). Data from previously transplanted patients with inf...
What is the current status of trial NCT05739643?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-02-03. Estimated completion is 2026-11.
What conditions does trial NCT05739643 study?
This clinical trial studies the following conditions: Krabbe Disease.
What interventions are being tested in trial NCT05739643?
The interventions under investigation include: FBX-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05739643?
This trial is sponsored by Forge Biologics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05739643 being conducted?
This trial has 3 study locations across California, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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