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Tiny study aims to Fine-Tune antibody therapy for rare immune disorders

NCT ID NCT07516002

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

5 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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  2. A doctor treating you

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