RecruitingNot ApplicableNCT03727555

IT and IV Lentiviral Gene Therapy for X-ALD

Intrathecal and Intravenous Lentiviral Gene Therapy for X-linked Adrenoleukodystrophy (X-ALD)


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

Aug 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I/II clinical trial of gene therapy for treating X-linked adrenoleukodystrophy using a high-safety, high-efficiency, self-inactivating lentiviral vector (LV) TYF-ABCD1 to functionally correct the defective gene. The objectives are to evaluate the safety and efficacy of the intrathecal and intravenous lentiviral gene transfer clinical protocol.


Eligibility

Min Age: 1 YearMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Intrathecal and intravenous LV gene therapy for people with x-linked adrenoleukodystrophy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Year to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICIntrathecal and intravenous LV gene therapy

Direct IT and IV LV gene therapy to deliver high levels of LVs at 1-2×10\^9 multiplicity of infection/ml which carry normal ABCD1 gene


Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

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NCT03727555


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