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Gene Therapy Trial Report

Summary

Efficacy and Safety of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

NCTID NCT06743646 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Bietti Crystalline Dystrophy
Disease Ontology Term DOID:0050664
Compound Name ZVS101e
Compound Alias puliretgene parvec
Compound Description rAAV2/8-hCYP4V2
Sponsor Chigenovo Co., Ltd
Funder Type Network
Recruitment Status
Enrollment Count 62 (ESTIMATED)
Results Posted Not Available

Therapy Information

Target Gene/Variant CYP4V2
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Subretinal
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type AAV2/8
Editor Type none
Dose 1 Phase 1/2: 7.5E10 vg/eye
Dose 2 Phase 1/2: 1.5E11 vg/eye
Dose 3 Phase 1/2: 2.2E11 vg/eye
Dose 4 Expansion/pivotal dose: 7.5E10 vg/eye
Dose 5

Study Record Dates

Current Stage Phase3
Submit Date 2024-12-17
Completion Date 2030-06-30
Last Update 2025-01-03

Participation Criteria

Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 8
Locations China

Regulatory Information

Has US IND False
FDA Designations
Recent Updates

Resources/Links

Clinical Publications
Preclinical Publications
Related NCTID