New hope for kids with rare immune disease: leniolisib trial launches

NCT ID NCT05693129

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called leniolisib in children aged 1 to 6 years who have a rare genetic immune disorder called APDS. The drug aims to control the overactive immune system and reduce swollen lymph nodes. Researchers will monitor safety and how well the drug works over time.

What this could mean

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

Active substance
leniolisib
What this could lead to
If successful, leniolisib could offer a targeted treatment option to control APDS in young children, reducing infections and lymph node problems.
What could go wrong
This is a small, early-phase trial with only 16 children, so results may not apply to all. Side effects and long-term safety are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Great Ormond Street Hospital

    London, WC1N3JH, United Kingdom

  • Hospital Pediátrico de Coimbra da ULS Coimbra UNIDADE LOCAL DE SAÚDE DE COIMBRA

    Coimbra, 3000-075, Portugal

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Institute of Science Tokyo Hospital

    Tokyo, 113-8519, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • National Institutes of Health

    Bethesda, Maryland, 20814, United States

  • Rainbow Childrens Hospital

    Shaker Heights, Ohio, 44122, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

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