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ACTIVE NOT RECRUITING Phase 1

Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT

NCT05739643 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 9 participants
Start Date 2023-02-03
Est. Completion 2026-11
Phase Phase 1

Sponsor

Forge Biologics

2 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forge Biologics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05739643 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Michigan, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05739643?

The interventions under investigation include: FBX-101 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05739643?

This trial is sponsored by Forge Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial