Gene therapy boost for krabbe patients after transplant

NCT ID NCT05739643

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a single infusion of a gene therapy called FBX-101 in 9 people with Krabbe disease who have already received a stem cell transplant. The therapy uses a harmless virus to deliver a working copy of the GALC gene, aiming to improve motor function and safety. Researchers will compare results to patients who only had the transplant.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

FBX-101 (a gene therapy that delivers a working copy of the GALC gene via a harmless virus)

What this could lead to

If successful, this could improve motor function and slow disease progression for people with Krabbe disease who have already had a stem cell transplant.

What could go wrong

This is a very early, small trial (9 people) focused mainly on safety. The gene therapy may not provide additional benefit beyond the transplant, and there are unknown risks from the virus and gene insertion.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn brain disorder central nervous system disorder demyelinating disease Hereditary Central Nervous System Demyelinating Diseases hereditary disease inborn errors of metabolism Krabbe disease Leukoencephalopathies Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors lysosomal lipid storage disorder lysosomal storage disease Lysosomal Storage Diseases, Nervous System metabolic disease nervous system disorder sphingolipidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Children's Hospital of Orange County (CHOC)

    Orange, California, 92868, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • University of Michigan Hospitals - Michigan Medicine

    Ann Arbor, Michigan, 48109, United States