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Leniolisib for Immune Dysregulation in CVID
NCT06897358 · View on ClinicalTrials.gov ↗
Study Summary
In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerability of leniolisib, and secondary goal is to assess the potential for leniolisib to provide benefits for patients.
Conditions Studied
Interventions
- DRUG Leniolisib
Study Locations (7)
Other
- IIS La Fe — Valencia
- Leeds Teaching Hospital NHS Trust — Leeds
Colorado
- Children's Hospital Colorado — Aurora
Maryland
- National Institute of Health — Bethesda
Massachusetts
- Lahey Hospital & Medical Center — Burlington
New York
- Mount Sinai Hospital — New York
Texas
- Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-02-12 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06897358
The ClinicalTrials.gov registry entry for NCT06897358 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharming Technologies B.V., which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Common Variable Immunodeficiency (CVID) appearing as the primary indexed condition, and to 1 intervention — of which Leniolisib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06897358 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Other, Colorado, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06897358 about?
NCT06897358 is a clinical study titled "Leniolisib for Immune Dysregulation in CVID". In this study, common variable immunodeficiency (CVID) patients will all receive the study drug, leniolisib, for a treatment period of 6 months. Participants will start on a lower dose of leniolisib, followed by a mid and then a higher dose level. The primary goal is to assess the safety and tolerab...
What is the current status of trial NCT06897358?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-02-12. Estimated completion is 2026-10.
What conditions does trial NCT06897358 study?
This clinical trial studies the following conditions: Common Variable Immunodeficiency (CVID). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06897358?
The interventions under investigation include: Leniolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06897358?
This trial is sponsored by Pharming Technologies B.V., which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06897358 being conducted?
This trial has 7 study locations across Colorado, Maryland, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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