Peripheral Helper T-cells in Common Variable ImmunoDeficiency (NCT07255157) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peripheral Helper T-cells in Common Variable ImmunoDeficiency
France60 participantsStarted 2025-12
Plain-language summary
The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female;
* Age ≥ 18 years;
* Standard criteria will be applied to diagnose CVID, specifically requiring: 1) low serum IgG level \<5 g/L, combined with low IgM- and/or IgA-isotype concentrations \<0.4 g/L or \<0.7 g/L, respectively; 2) poor antibody responses to immunization or infection; and 3) exclusion of other defined forms of secondary hypogammaglobulinemias. Patients meeting the definitional criteria for CVID will be included, regardless of the duration of the disease or the treatment received (gammaglobulins substitution or not);
* Being affiliated to health insurance;
* Willing to participate and to sign informed consent.
Exclusion Criteria:
* Patients on corticosteroids and/or immunosuppressants;
* Patients with a primary immunodeficiency genetically characterized, such as Bruton disease our HyperIgM syndrome;
* Patients with an active chronic infection;
* Pregnant or breastfeeding women;
* Persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)