Clinical Trial

ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-02-19; most recent amendment 2026-05-13.
Status change: Active, Not Recruiting → Recruiting 2025-09-11
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-07-25
Trial Details
NCT Number NCT06838676
Lead Sponsor Nationwide Children's Hospital
Collaborators: Accendatech USA Inc.
Conditions Diffuse Intrinsic Pontine Gliomas (DIPG), Progressive DIPG, Refractory DIPG, Recurrent DIPG, H3K27-altered High Grade Glioma
Enrollment 60 participants
Start Date 2025-07-10
Primary Completion 2028-07 (estimated)
Study Completion 2035-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-12