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Assessing antibodies and cytokines in patients with Chronic Granulomatous Disease

A Cross-Sectional, Observational Study of the Prevalence of Adenoviral-Specific Antibodies and Inflammatory Cytokines in Participants With Chronic Granulomatous Disease

Observational Ensoma · NCT06605378

This study looks at the levels of certain antibodies and inflammation markers in people with Chronic Granulomatous Disease to better understand their immune response.

Quick facts

Study typeObservational
Enrollment60 (estimated)
SexAll
SponsorEnsoma Industry-sponsored
Locations52 sites (Montgomery, Alabama and 51 other locations)
Trial IDNCT06605378 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the prevalence of specific antibodies and inflammatory cytokines in individuals diagnosed with Chronic Granulomatous Disease (CGD). Blood samples will be collected from both adult and pediatric participants to measure levels of circulating adenovirus antibodies and inflammatory cytokines. The findings will help characterize the immune response in this patient population and may provide insights into disease management.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Chronic Granulomatous Disease, confirmed by low NADPH oxidase activity or pathogenic mutations in associated genes.

Not a fit: Patients who have undergone an allogeneic bone marrow transplant or investigational gene therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of CGD and inform future therapeutic strategies.

How similar studies have performed: While this study focuses on the prevalence of specific markers in CGD, similar observational studies have shown success in characterizing immune responses in other conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive \[DHR+\] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1).
* The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent.
* The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF).

Exclusion Criteria:

* The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy.
* The participant is unable to comply with the sample collection procedure based on investigator judgment.

Where this trial is running

Montgomery, Alabama and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Granulomatous DiseaseCGDX-CGDGranulomatous Disease, ChronicAutosomal Recessive Chronic Granulomatous Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.