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MT2024-38: 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

Status: Recruiting

To evaluate the safety of the EN-374 treatment regimen (HSC mobilization, immune prophylaxis, EN-374 dose and administration, and enrichment of HSCs with O6BG/TMZ).

I'm interested

Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old for initial phase of the study and then at least 3 months old for later phase
• diagnosis of X-CGD
• history of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
• does not have a suitable, available and willing human related donor
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active infection
• history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• had investigational gene therapy
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions:

Rare Diseases

Keywords:

chronic granulomatous disease, recurrent bacterial or fungal infections, X-CGD

Study Contact: Christen Ebens - ebens012@umn.edu
Principal Investigator: Christen Ebens
Phase: PHASE1
IRB Number: STUDY00025676
See this study on ClinicalTrials.gov

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