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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 HSCT. 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