Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).

Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG). - WT1-W10 immunotherapy against DMG (WT1-TR-DMG)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025452

Enrollment

Registered

2017-01-04

Start date

2017-01-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma multiforme

Interventions

Standard radio-chemotherapy using wither 1) or 2) below will be combined. 1)Temozolomide (TMZ) + WT1-W10 peptide 2)Temozolomide (TMZ) + bevacizumab (BV) + WT1-W10 peptide 1.WT1-W10 peptide immu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Diagnosed as diffuse midline glioma (DMG) and competent to receive standard radio-chemotherapy using TMZ. A further inclusion of BV is permissive. 2)3 - 17 years of age 3)Carrying one or two of HLA-A*24:02, A*02:01, A*02:06, A*02:07 genes 4)The tumor overexpresses WT1 protein (optional for the cases where tumor tissue has been obtained) 5)Karnofsky Index > 60% or performance status : 0-2 6)Expected survival > 3 months 7)No serious impairment of the heart, lung, liver, kidney and bone marrow 8)Without serious diseases aside from DMG, no double cancers including malignancies of the hematopoietic organs 9)Written consent from the parents and/or patient is obtained.

Exclusion criteria

Exclusion criteria: One or more of the following criteria leads to exclusion of the subject. 1)Uncontrollable infections, including active tuberculosis 2)Severe comorbidities (e.g. malignant hypertension, severe congestive heart disease, severe ischemic heart disease, myocardial infarction within 3 months, end-stage liver insufficiency, uncontrollable diabetes mellitus, severe pneumonitis etc.) 3)After the bone marrow implantation 4)Severe psychological disorders 5)Being enrolled in other clinical trials 6)Once enrolled in this study, but was disqualified for some reasons (Double enrollment is prohibited.) 7)Disqualified by the doctors due to some medical, psychological and/or social problems

Design outcomes

Primary

Measure	Time frame
Degree and frequency of adverse events (> grade 3)	—

Countries

Japan

Contacts

Public ContactYu Kawanishi

Kochi Medical School Department of Pedicatrics

vaccine@kochi-u.ac.jp088-880-2355

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026