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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
Indication Herpes Simplex Virus Type I Stromal Keratitis
Compound Name BD111
Sponsor Shanghai BDgene Co., Ltd.
Funder Type Industry
Status
Not yet recruiting
Enrollment Count 40

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 1.25 x 10^6 TU/eye
Dose 2 2.5 x 10^6 TU/eye
Dose 3 5.0 x 10^6 TU/eye
Dose 4 10 x 10^6 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
Eligible Sex ALL

Locations

No.of Trial Sites 1
Locations China

Regulatory Information

Has US IND False
Recent Updates

Resources/Links

Patents
  • WO2024011980A1
Clinical Publications
Preclinical Publications