Common Variable ImmunodeficiencyTAPDINCT07255157
Peripheral Helper T-cells in Common Variable ImmunoDeficiency
A study testing blood sample in people with Common Variable Immunodeficiency, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Variable Immunodeficiency
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de médecine interne
Pessac
Jean-François VIALLARD, Prof, (0)5.57.65.64.83 ext. +33, jean-françois.viallard@chu-bordeaux.fr
Carine LOPEZ, (0)5.24.54.91.32 ext. +33, carine.lopez@chu-bordeaux.fr
About this study
Official title: Deciphering the Role of Peripheral Helper T-cells in Common Variable ImmunoDeficiency Pathophysiology in Patients With Non-infectious Complications
The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.
Read the detailed description
Common variable immunodeficiency (CVID), the most common symptomatic primary immunodeficiency in adults, can associate recurrent infections with severe non-infectious complications. Unfortunately, there is still no absolute biomarker predicting which CVID patient will develop non-infectious complications. Thus, novel biomarkers which could help refining CVID patient prognosis require further investigations. Moreover, the immune mechanisms driving non-infectious complications remain elusive. Therefore, further insight into CVID pathophysiology is needed to discover new treatments for CVID patients with non-infectious complications (CVIDc). The preliminary results show that CVIDc patients have an increase of circulating peripheral helper T-cells (Tph) , in comparison with patients with infectious manifestations only (CVIDi) and healthy individuals (HI). Recently described, Tph express CXCR3, help memory B-cells and are found in inflamed tissues in auto-immune diseases. They represent a major reservoir of auto-reactive T-cells, suggesting that Tph are key to drive auto-immune processes. Some authors hypothesized that Tph can help atypical memory B-cells (ABCs), a B-cell subset which is involved in auto-immune disease pathophysiology and which is also expanded in CVIDc patients. The investigators observed that CXCR3+ cells were increased in the spleen of CVIDc patients in comparison with non-CVID controls. These CXCR3+ cells could correspond to Tph supporting extra-follicular reaction and then B-cell tolerance loss. The hypothesis is that alterations in T-B cell collaboration leads to the amplification of Tph in CVID patients. Tph could support non-infectious complications in target tissues through providing help to pathological B-cells such as ABCs. Using peripheral blood from CVIDc/CVIDi patients and HI, the investigators will determine whether Tph support pathological B cell activation in CVIDc patients using T-B co-cultures. Patients will be included during their routine follow-up, for one day.
- Conditions
- Common Variable Immunodeficiency
- Being tested
- blood sample
- Keywords
- common variable immunodeficiency, peripheral helper T cells, B cells
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
| Study group | Role | What they receive |
|---|---|---|
| Common variable immunodeficiency | Experimental | Not described Receives: Other: blood sample |
| Controls | Active comparator | Healthy controls Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start9 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Variable ImmunodeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François VIALLARD, Prof, Principal investigator, University Hospital, BordeauxJonathan VISENTIN, Prof, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255157
- Sponsor's protocol ID
- CHUBX 2025/037
- Other IDs
- 2025-A01348-41
- Acronym
- TAPDI
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Role of Peripheral Helper T-cells in Common Variable ImmunoDeficiency Pathophysiology in Patients With Non-infectious Complications
- ClinicalTrials.gov ID
- NCT07255157
- Acronym / sponsor ID
- TAPDI / CHUBX 2025/037
- Conditions
- Common Variable Immunodeficiency
- Keywords
- common variable immunodeficiency, peripheral helper T cells, B cells
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.
Detailed description
Common variable immunodeficiency (CVID), the most common symptomatic primary immunodeficiency in adults, can associate recurrent infections with severe non-infectious complications. Unfortunately, there is still no absolute biomarker predicting which CVID patient will develop non-infectious complications. Thus, novel biomarkers which could help refining CVID patient prognosis require further investigations. Moreover, the immune mechanisms driving non-infectious complications remain elusive. Therefore, further insight into CVID pathophysiology is needed to discover new treatments for CVID patients with non-infectious complications (CVIDc). The preliminary results show that CVIDc patients have an increase of circulating peripheral helper T-cells (Tph) , in comparison with patients with infectious manifestations only (CVIDi) and healthy individuals (HI). Recently described, Tph express CXCR3, help memory B-cells and are found in inflamed tissues in auto-immune diseases. They represent a major reservoir of auto-reactive T-cells, suggesting that Tph are key to drive auto-immune processes. Some authors hypothesized that Tph can help atypical memory B-cells (ABCs), a B-cell subset which is involved in auto-immune disease pathophysiology and which is also expanded in CVIDc patients. The investigators observed that CXCR3+ cells were increased in the spleen of CVIDc patients in comparison with non-CVID controls. These CXCR3+ cells could correspond to Tph supporting extra-follicular reaction and then B-cell tolerance loss. The hypothesis is that alterations in T-B cell collaboration leads to the amplification of Tph in CVID patients. Tph could support non-infectious complications in target tissues through providing help to pathological B-cells such as ABCs. Using peripheral blood from CVIDc/CVIDi patients and HI, the investigators will determine whether Tph support pathological B cell activation in CVIDc patients using T-B co-cultures. Patients will be included during their routine follow-up, for one day.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Common variable immunodeficiency | Experimental | Other: blood sample |
| Controls | Active comparator | Other: blood sampleHealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation | Other | Common variable immunodeficiency, Controls |
Primary outcome
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)
Time frame: At baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Common Variable Immunodeficiency
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Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)
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Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
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Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
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Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-François VIALLARD, Prof principal investigator
University Hospital, Bordeaux
Jonathan VISENTIN, Prof study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Common Variable Immunodeficiency, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François VIALLARD, Prof ((0)5.57.65.64.83 ext. +33, jean-françois.viallard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture) (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.