RecruitingPhase 1Phase 2NCT06876363

Study of EN-374 Gene Therapy in Participants With X-Linked Chronic Granulomatous Disease

A Phase 1/2 Open-Label, Single-Ascending-Dose Study of EN-374, a Helper-Dependent Adenoviral-Based Gene Therapy, in Participants With X-Linked Chronic Granulomatous Disease


Sponsor

Ensoma

Enrollment

15 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and potential efficacy of the EN-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease. The main questions it aims to answer are: * safety of the EN-374 treatment regimen * effect of the EN-374 treatment regimen on the production of functional neutrophils with NADPH oxidase activity


Eligibility

Sex: MALEMin Age: 3 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying EN-374 for people with x-linked chronic granulomatous disease. The study is currently recruiting participants at 9 locations.

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

GENETICEN-374

Single dose of EN-374 administered by intravenous infusion after mobilization and followed by enrichment


Locations(9)

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Columbia University Irving Medical Center, Morgan Stanley Children's Hospital

New York, New York, United States

Duke University

Durham, North Carolina, United States

University of Utah, Primary Children's Hospital

Salt Lake City, Utah, United States

University College London Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06876363


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