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NOT YET RECRUITING
NCT06952842
PHASE1/PHASE2

Safety and Efficacy of ZVS203e in the Treatment of Retinitis Pigmentosa Caused by RHO Gene Mutation

Sponsor: Chigenovo Co., Ltd

View on ClinicalTrials.gov

Summary

This trial employs a single-arm, open-label seamless Phase I/II design, consisting of two stages: Phase I dose exploration and Phase II dose expansion.The primary objective of this trial is to evaluate the safety, tolerability, and efficacy of subretinal injection of ZVS203e solution.

Official title: A Single-Arm, Open-Label, Phase 1/2 Clinical Trial of ZVS203e in Subjects With Retinitis Pigmentosa Associated With RHO Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-05-18

Completion Date

2045-06-18

Last Updated

2025-05-01

Healthy Volunteers

No

Interventions

DRUG

ZVS203e

ZVS203e injection is a clear, transparent liquid containing a recombinant adeno-associated virus serotype 8 (rAAV8) vector that expresses humanized SauriCas9 protein and single guide RNA (sgRNA) targeting specific mutations in the RHO gene.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China