Actively Recruiting

Early Phase 1
Age: 2Years - 10Years
All Genders
NCT06860672

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

Led by Yongguo Yu · Updated on 2025-03-06

1

Participants Needed

1

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of Snijders Blok-Campeau syndrome
  • Heterozygous mutation of c.3073C>T, p.(Arg1025Trp) in the CHD3 gene
  • Normal liver, heart and immune function
  • Normal coagulation and platelet counts
Not Eligible

You will not qualify if you...

  • Brain tumor or intracranial space-occupying lesion
  • Contraindications to lumbar puncture or sheath injection
  • Persistent status epilepticus or unstable epilepsy control
  • Unstable systemic disease including active bacterial, fungal, HIV, hepatitis A or B infections
  • Serum anti-AAV neutralizing antibody titer >1:50
  • Treatment with immunological agents other than specified prophylaxis within 3 months
  • Prior gene therapy
  • Participation in another clinical trial or investigational treatment within 30 days or 5 half-lives
  • Known allergy to any investigational product

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200092

Actively Recruiting

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Research Team

X

Xiaomei Luo, Ms., Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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