NCT07255157

Brief Summary

The aim is to determine whether whether Tph could support non-infectious complications through providing help to pathological B-cells.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 10, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

November 19, 2025

Last Update Submit

December 2, 2025

Conditions

Common Variable Immunodeficiency

Keywords

common variable immunodeficiencyperipheral helper T cellsB cells

Outcome Measures

Primary Outcomes (1)

  • Ability of Tph to promote differentiation and antibody production by memory B cells (B-T co-culture)

    At baseline (Day 0)

Study Arms (2)

Common variable immunodeficiency

EXPERIMENTAL
Other: blood sample

Controls

ACTIVE COMPARATOR

Healthy controls

Other: blood sample

Interventions

blood sampleOTHER

48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

Common variable immunodeficiencyControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female;
  • Age ≥ 18 years;
  • Being affiliated to health insurance;
  • Willing to participate and to sign informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de médecine interne

Pessac, France

Location

MeSH Terms

Conditions

Common Variable Immunodeficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-François VIALLARD, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Jonathan VISENTIN, Prof

    University Hospital, Bordeaux

    STUDY DIRECTOR

Central Study Contacts

Jean-François VIALLARD, Prof

CONTACT

(0)5.57.65.64.83jean-françois.viallard@chu-bordeaux.fr

Carine LOPEZ

CONTACT

(0)5.24.54.91.32carine.lopez@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 10, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)