Assessing antibodies and cytokines in patients with Chronic Granulomatous Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Home-based telemedicine
  Montgomery, Alabama, United States Recruiting
• Home-based telemedicine
  Phoenix, Arizona, United States Recruiting
• Home-based telemedicine
  Little Rock, Arkansas, United States Recruiting
• Home-based telemedicine
  Sacramento, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Home-based telemedicine
  Denver, Colorado, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Andrew Dietz, MD, MSCR
• Email: ddietz@ensoma.com
• Phone: 617-766-3917

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Open-label gene therapy for p47-CGD in adults and children over 18 months

  This gene therapy study tests SGX-001 to help people with p47-CGD caused by NCF1 mutations.

  Recruiting Phase 1/2 Somagenetix AG · Ulm and 2 other locations · NCT07826767

• Base editing of blood stem cells to fix the CYBB mutation in X-linked chronic granulomatous disease.

  This trial will try base-editing a person's own blood stem cells to fix a specific CYBB mutation in adult men with X-linked chronic granulomatous disease.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06325709

• Evaluation of patients with immune function abnormalities

  This study is testing how immune problems affect people with conditions like XSCID and CGD to help find better treatments and understand their health over time.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT00128973

• Ibuprofen with G‑CSF and Plerixafor to mobilize stem cells for people with X‑CGD

  This trial will test whether adding ibuprofen to G‑CSF and plerixafor helps collect enough stem cells for adults with X‑linked chronic granulomatous disease.

  Recruiting at 2 sites Phase 2 IRCCS San Raffaele · Rome, Lazio and 1 other locations · NCT03055247

• Reduced-intensity hematopoietic stem cell transplant for CVID and other primary immune regulatory disorders

  This will try a reduced-intensity hematopoietic stem cell transplant with low-dose total body irradiation to correct or improve severe CVID and related primary immune regulatory disorders in people aged 5 to 40.

  Recruiting Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07284641

• Transplantation for Chronic Granulomatous Disease using a new drug regimen

  This study is testing a new drug combination to see if it can improve the success of stem cell transplants for people aged 4 to 65 with Chronic Granulomatous Disease who have serious complications.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05463133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.