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

Krabbe Disease Clinical Trial

Official title:
A Phase 1b Clinical Study of Intravenous AAVrh10 Vector Expressing GALC in Krabbe Subjects Who Previously Received Hematopoietic Stem Cell Transplantation (REKLAIM)

Clinical Trial 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.

Clinical Trial Description

The FBX-101-REKLAIM study has been modified on Q4 2023 to allow a broader patient recruitment of infantile and late infantile Krabbe patients. The updated REKLAIM study merges the recruitment populations of the previous FBX-101-RESKUE clinical trial (NCT04693598) and the FBX-101-REKLAIM clinical trial (NCT05739643). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05739643
Study type Interventional
Source Forge Biologics, Inc
Contact Kelly Bossola
Phone +1.380.239.2052
Email advocacy@forgebiologics.com
Status Recruiting
Phase Phase 1/Phase 2
Start date February 3, 2023
Completion date July 2026
View Details
See also
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Active, not recruiting NCT00787865 - Diffusion Tensor Imaging (DTI) in Infants With Krabbe Disease