A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas

Summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.

Timeline

Start

2016-04

Primary completion

2020-01

Completion

2020-01

Outcome

Missed primary endpoint

paper the lower limit of the 90% CI for the primary efficacy endpoint in DIPG patients did not exceed its prespecified threshold-20%. PMID 42176363 ↗

paper The vaccine was not effective statistically PMID 42176363 ↗

Publications

• Hashii Y, Fujisaki H, Terashima K, Goto H, Horibe K, Sugiyama K, Takahara-Matsubara M, Goto M, Yanagisawa T, Kikuta A, Kawamoto H, Hashimoto N, Oka Y, Sugiyama H, Hara J. Phase 1/2 study of a WT1 peptide-dosing emulsion in pediatric patients with recurrent/refractory diffuse intrinsic pontine glioma, glioblastoma, or anaplastic astrocytoma. Eur J Cancer. 2026 Jun 25;242:116808. doi: 10.1016/j.ejca.2026.116808. Epub 2026 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ombipepimut-S	Vaccine	1.75 mg	Other
Subject	ombipepimut-S	Vaccine	3.5 mg	Other

Indications