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Scientists hunt for better ways to track rare immune disease

NCT ID NCT06694363

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to find new biomarkers to better screen and monitor Activated PI3K Delta Syndrome (APDS), a rare immune disorder. Researchers will collect blood, urine, and stool samples from 14 APDS patients over two years to analyze changes in immune cells and other markers. The goal is to improve disease tracking and treatment monitoring, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to diagnose and monitor APDS, helping doctors tailor treatments more effectively.
What could go wrong
This is a very small, early-stage study with only 14 participants, so results may not apply broadly. It focuses on finding biomarkers, not testing a new treatment.

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 14 people

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

Started

Jun 2025

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 genetic diagnosis of APDS type 1 or type 2 and planned to be treated by PI3Kδ selective inhibitor leniolisib and patients with genetic diagnosis of APDS type 1 or type 2 already treated by PI3Kδ selective inhibitor leniolisib in the last 2 years

Ages

12 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: Group 1: * Patients with genetic diagnosis of APDS type 1 or type 2 and planned to be treated by PI3Kδ selective inhibitor leniolisib * Primary immunodeficient patients with new disease-causing variants in the PIK3CD gene or PIK3R1 gene * Minimum age 12 years old * Patients or holders of parental authority do not oppose participation in this research. * Patients affiliated to a Health Insurance scheme or beneficiaries Group 2 : * Patients with genetic diagnosis of APDS type 1 or type 2 already treated by PI3Kδ selective inhibitor leniolisib in the last 2 years * Patients whose pre-treatment samples are available/analyzable * Minimum age 12 years old * Patients or holders of parental authority do not oppose participation in this research. * patients affiliated to a Health Insurance scheme or beneficiaries Exclusion Criteria: * Bone marrow transplantation * Refusal to participate to the study.

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Conditions

The condition(s) this trial relates to.

activated PI3K-delta syndrome immunodeficiency 14

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Activated PI3K delta syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU IUCT Oncopole - TOULOUSE

    NOT_YET_RECRUITING

    Toulouse, France

  • Hôpital Haut Levêque - BORDEAUX

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Hôpital Jeanne de Flandres - LILLE

    RECRUITING

    Lille, 59000, France

  • Hôpital La Timone adulte - MARSEILLE

    NOT_YET_RECRUITING

    Marseille, 13000, France

  • Hôpital Necker Enfants Malades - PARIS

    RECRUITING

    Paris, 75015, France

  • Hôpital Pellerin Enfants - BORDEAUX

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Hôpital des enfants - TOULOUSE

    NOT_YET_RECRUITING

    Toulouse, France