Leniolisib for Immune Dysregulation in CVID (NCT06897358) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Leniolisib for Immune Dysregulation in CVID
United States20 participantsStarted 2025-02-12
Plain-language 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.
Who can participate
Age range12 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is 12 to 75 years of age (inclusive).
✓. Subject must have a minimum body weight of 45 kg
✓. Subject has a clinical diagnosis of CVID supported by all of the following (a thru c):
✓. A low IgG level compared to age-adjusted reference range \[OR if this cannot be documented, subject must have one of the following: i) absent isohemagglutinins and/or poor response to vaccines; or ii) Low class-switched memory B cells less than 2%\]
✓. Low IgA and/or IgM compared to age-adjusted reference range
✓. No identified secondary causes of hypogammaglobulinemia
✓. Inborn Errors of Immunity/ PID Panel testing:
✓. Lacks an identified pathogenic/likely pathogenic genetic driver for their CVID primary immunodeficiency OR
Exclusion criteria
✕. Laboratory evidence of significant T cell deficiency including CD4+ T cells \<200/uL.
✕. Laboratory evidence of significant NK cell deficiency including NK cells \<1% of peripheral blood lymphocytes or less than 50/mcL.
✕. Clinical history of infections suggestive of clinically significant T cell or NK cell deficiency such as Pneumocystis jirovecii, atypical mycobacteria, severe warts, or unusually severe (as determined by the PI) infections with herpesviruses.
What they're measuring
1
Safety & Tolerability
Timeframe: From baseline to the end of 24 weeks of treatment