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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Fabry Disease Gene Therapy Study
NCTID
NCT04040049
(View at clinicaltrials.gov)
Description
This is a multinational, open-label study to assess the safety and efficacy of FLT190 in up to 15 adult male participants with classical Fabry disease.
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Development Status
Inactive
Indication
Fabry Disease
Disease Ontology Term
DOID:14499
Compound Name
FLT190
Compound Description
AAV2/S3.FRE1.GLAco
Sponsor
Spur Therapeutics
Funder Type
Industry
Recruitment Status
Terminated
Enrollment Count
3
Results Posted
Not Available
Therapy Information
Target Gene/Variant
GLA
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Functional gene replacement
Route of Administration
Intravenous
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAVS3
Editor Type
Dose 1
7.5E11 vg/kg
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2019-07-26
Completion Date
2023-05-02
Last Update
2023-06-05
Participation Criteria
Eligible Age
>=18 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
MALE
Locations
No.of Trial Sites
13
Locations
Canada,Austria,United States,Norway,Italy,United Kingdom,Germany
Regulatory Information
Has US IND
True
FDA Designations
Recent Updates
Development cancelled to prioritize other programs
Resources/Links
News and Press Releases
Freeline pauses development of Fabry disease gene therapy FLT190
Freeline Reports New Data from Fabry Disease Program, Pipeline and Company Updates, Including Appointment of Pamela Foulds, MD as Chief Medical Officer, and Third Quarter 2021 Financial Results
Preclinical Publications
Preclinical evaluation of FLT190, a liver-directed AAV gene therapy for Fabry disease