Contact SCGE




Clinical Trial Report

Gene Therapy Trial Report

Summary

A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)


NCTID NCT05394064 (View at clinicaltrials.gov)
Description
Indication AMN, AMN Gene Mutation, X-ALD
Compound Name SBT101
Sponsor SwanBio Therapeutics, Inc.
Funder Type Industry
Status
Recruiting
Enrollment Count 16

Therapy Information


Target Gene/Variant ABCD1
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intrathecal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV9
Editor Type none
Dose 1 1.0E14 vg
Dose 2 3.0E14 vg
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2022-05-16
Completion Date 2029-03-30
Last Update 2023-09-13

Participation Criteria


Eligible Age 18 Years - 65 Years
Standard Ages Adult, Older adult
Eligible Sex MALE

Locations


No.of Trial Sites 2
Locations Netherlands,United States

Regulatory Information


Has US IND True
Recent Updates

Resources/Links