Contact SCGE
Your email
Message
Send
SCGE Consortium Home
About SCGE TCDC
Contact Us
License
Home
Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCTID
NCT05672121
(View at clinicaltrials.gov)
Description
KH631 is a adeno-associated virus (AAV) vector-based gene therapy for subretinal injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.
(Show More)
Development Status
Active
Indication
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
KH631
Sponsor
Chengdu Origen Biotechnology Co., Ltd.
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
42
Results Posted
Not Available
Therapy Information
Target Gene/Variant
VEGFR1/R2 fusion protein
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Genetic delivery of therapeutic protein
Route of Administration
Intravitreal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV8
Editor Type
none
Dose 1
5 undisclosed dose levels (200ul/dose)
Dose 2
Dose 3
Dose 4
Dose 5
Study Record Dates
Current Stage
Phase1, Phase2
Submit Date
2022-12-21
Completion Date
2026-12-28
Last Update
2024-11-27
Participation Criteria
Eligible Age
50 Years - 85 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
Resources/Links
News and Press Releases
Chengdu Origen and Vanotech Announce First Patient Dosed in VAN-2201 Phase 1 Trial of Gene Therapy for Wet Age-Related Macular Degeneration
Preclinical Publications
Preclinical evaluation of KH631, a novel rAAV8 gene therapy product for neovascular age-related macular degeneration
Related NCTID
Phase 1: NCT05657301