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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
NCTID
NCT06474442
(View at clinicaltrials.gov)
Description
This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.
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Development Status
Active
Indication
Herpes Simplex Virus Type I Stromal Keratitis
Disease Ontology Term
DOID:0080158
Compound Name
BD111
Sponsor
Shanghai BDgene Co., Ltd.
Funder Type
Industry
Recruitment Status
Not yet recruiting
Enrollment Count
40
Results Posted
Not Available
Therapy Information
Target Gene/Variant
HSV genes
Therapy Type
Gene editing
Therapy Route
In-vivo
Mechanism of Action
Gene excision
Route of Administration
Intrastromal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
LV
Editor Type
SpCas9 mRNA
Dose 1
1.25E6 TU/eye
Dose 2
2.5E6 TU/eye
Dose 3
5.0E6 TU/eye
Dose 4
10E6 TU/eye
Dose 5
Study Record Dates
Current Stage
Phase2
Submit Date
2024-06-13
Completion Date
2026-12
Last Update
2024-06-25
Participation Criteria
Eligible Age
18 Years - 70 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
Orphan Drug Designation
Recent Updates
Resources/Links
Clinical Publications
In vivo CRISPR gene editing in patients with herpetic stromal keratitis
Preclinical Publications
Targeting herpes simplex virus with CRISPR-Cas9 cures herpetic stromal keratitis in mice
Related NCTID
Phase Not Applicable: NCT04560790
Phase 1: NCT06474416