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Clinical Trial NCT07255157 (TAPDI) for Common Variable Immunodeficiency is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Peripheral Helper T-cells in Common Variable ImmunoDeficiency (TAPDI)

Not yet recruiting
Clinical Trial NCT07255157 (TAPDI) is an interventional study for Common Variable Immunodeficiency is not yet recruiting. Enrollment is planned to begin on 1 December 2025 until the trial accrues 60 participants. Led by University Hospital, Bordeaux, this trial is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 28 November 2025.
Brief Summary
Our 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). Our 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 ivestigators 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. Our 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.
Official Title

Deciphering the Role of Peripheral Helper T-cells in Common Variable ImmunoDeficiency Pathophysiology in Patients With Non-infectious Complications

Conditions
Common Variable Immunodeficiency
Other Study IDs
  • TAPDI
  • CHUBX 2025/037
NCT ID Number
NCT07255157
Start Date (Actual)
2025-12
Last Update Posted
2025-11-28
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
common variable immunodeficiency
peripheral helper T cells
B cells
Primary Purpose
Other
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCommon variable immunodeficiency
Blood Sample
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Active ComparatorControls
Healthy controls
Blood Sample
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)
At baseline (Day 0)
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

  • Patients on corticosteroids and/or immnosuppressants;
  • 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.
University Hospital, Bordeaux logoUniversity Hospital, Bordeaux
Study Central Contact
Contact: Jean-François VIALLARD, Prof, (0)5.57.65.64.83, jean-franç[email protected]
Contact: Carine LOPEZ, (0)5.24.54.91.32, [email protected]
1 Study Locations in 1 Countries
CHU de Bordeaux - service de médecine interne, Pessac, France
Jean-François VIALLARD, Prof, Contact, (0)5.57.65.64.83, jean-franç[email protected]
Carine LOPEZ, Contact, (0)5.24.54.91.32, [email protected]
Jean-François VIALLARD, Prof, Principal Investigator
Estibaliz LAZARO, Prof, Sub-Investigator
Carine GREIB, MD, Sub-Investigator
Camille PROT-LEURENT, MD, Sub-Investigator
Pierre DUFFAU, Prof, Sub-Investigator
Emmanuel RIBEIRO, MD, Sub-Investigator