Tiny study aims to Fine-Tune antibody therapy for rare immune disorders
NCT ID NCT07516002
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will follow 15 people with primary antibody immunodeficiency who are receiving immunoglobulin therapy. Researchers will track changes in specific immune cells (T and B cells) and infection rates over time. The goal is to see if these cell changes can help predict how well the therapy is working, potentially leading to more personalized treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- immunoglobulin (antibody replacement therapy)
- What this could lead to
- If successful, this could help doctors better tailor immunoglobulin therapy for patients with antibody immunodeficiency by tracking specific immune cell changes.
- What could go wrong
- This is a very small, early-stage observational study with only 15 participants, so results may not apply broadly. It focuses on measuring immune markers, not on proving a new treatment works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with primary antibody immunodeficiency, aged 18 years and older, who are receiving regular immunoglobulin replacement therapy at the study site. Exclusion criteria include active infection, recent immunosuppressive treatment, or prior hematopoietic stem cell transplantation.
- Ages
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5 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:Confirmed Diagnosis: Diagnosis of primary antibody immunodeficiency based on clinical presentation and laboratory evidence of impaired antibody production. Diagnoses should align with standard criteria (e.g., ESID/IUIS diagnostic criteria). Laboratory Evidence: Documented quantitative deficiency in serum immunoglobulins, defined as reduced IgG, IgA, and/or IgM levels below the age-adjusted lower limit of normal, and/or demonstrated poor specific antibody response to vaccines. Age: Patients aged between 5 and 50 years (inclusive) at the time of screening. Treatment Status: Currently receiving or scheduled to initiate regular immunoglobulin replacement therapy. Consent: Provision of written informed consent by the patient or their legal guardian, along with documented assent from pediatric participants where developmentally appropriate. \- Exclusion Criteria:Secondary Immunodeficiency: Presence of other severe comorbidities that may affect immune function. This specifically includes secondary causes of hypogammaglobulinemia, such as active malignancies, protein-losing enteropathy, nephrotic syndrome, or untreated HIV infection. Other PIDs: Confirmed diagnosis of primary immunodeficiency disorders other than predominantly antibody deficiency. Confounding Medications: Use of systemic immunosuppressive or targeted immunomodulatory drugs within 3 months prior to enrollment. Patients on stable immunoglobulin replacement therapy are exempt from this exclusion. Acute Confounding Illness: Presence of active, severe, uncontrolled infections at the time of baseline blood sampling that, in the investigator's clinical judgment, would transiently distort baseline immune subset profiling. Pregnancy/Lactation: Current pregnancy or breastfeeding, due to the physiological alterations in maternal immune subsets. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.