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RECRUITING
NCT06860672
EARLY_PHASE1

Clinical Trial of the Dual Vector Base Editor for the Treatment of the CHD3-R1025W Mutation

Sponsor: Yongguo Yu

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability and preliminary efficacy study of a single intrathecal injection of the dual vector AAV-CHD3-R1025W base editor for the treatment of developmental disorders caused by the R1025W mutation in the CHD3 gene

Official title: Safety, Tolerability and Preliminary Efficacy Study of a Single Intrathecal Injection of the Dual Vector AAV-CHD3-R1025W Base Editor for the Treatment of Developmental Disorders Caused by the R1025W Mutation in the CHD3 Gene

Key Details

Gender

All

Age Range

2 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2025-02-19

Completion Date

2025-09

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

GENETIC

Dual vector DNA base editor

The base editor is delivered using a dual vector adeno-associated virus (AAV) system and introduced into the child via intrathecal injection to correct the mutated CHD3 gene. The vital signs of the child will be closely monitored during treatment to assess possible acute adverse effects. The child will be followed up regularly after treatment to monitor the success of gene editing and the neurodevelopmental improvement of the child. Possible long-term adverse events will be closely monitored to assess the safety of the treatment.

Locations (1)

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China