Long-term maintenance of anti-tumor immune responses by vaccination with tri-WT1 peptide cancer vaccine WT1 Trio

Long-term maintenance of anti-tumor immune responses by vaccination with tri-WT1 peptide cancer vaccine WT1 Trio - Long-term anti-tumor immune responses by WT1 Trio

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023578

Enrollment

Registered

2016-09-10

Start date

2016-10-01

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

Thymic cancer Thymoma Soft tissue sarcoma Malignant glioma Salivary gland cancer Head and neck mucoepidermoid carcinoma Olfactory neuroblastoma Head and neck mucosal malignant melanoma Ophthalmic malignant melanoma Cancer of the external auditory canal Testicular cancer Cancer of penis Adrenal cancer Malignant mesothelioma Cancer of the small intestine Merkel cell carcinoma Cutaneous lymphoma (Rare cancers listed above)

Interventions

A patient is vaccinated with Montanide ISA51-adjuvanted WT1 Trio cancer vaccine consisting of two WT1 CTL peptides (WT1-126 and WT1-235) and one WT1 HTL peptide (WT1-332) (2mg each) seven times at the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 A patient who was treated with WT1 peptide vaccine in the clinical trial of WT1 Trio Peptide-vaccine for Rare Cancers. 2 A patient in whom tumor growth was slowed or suppressed during the treatment with WT1 Trio vaccine in the clinical trial of WT1 Trio Peptide-vaccine for Rare Cancers. 3 A patient without severe dysfunctions in his/her vital organs 4 Age; 16-85 years-old. 5 ECOG Performance Status, PS :0-1. PS 2 is allowed in a case with primary brain tumor if it is ascribed to neural dysfunctions caused by brain tumor. 6 Written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1 A patient with active infectious disease. 2 A patient who experienced SAE (grade >=4) in the previous clinical trial of WT1 peptide vaccine 3 A patient with severe complication or complications. 4 A patient with severe mental disorder. 5 A patient who participates in any other clinical trial 6 A patient who should not be recruited to the clinical trial as determined by the investigators

Design outcomes

Primary

Measure	Time frame
Induction of WT1-specific immune responses assessed by WT1-related tests such as WT1-DTH skin reaction, serum levels of WT1 peptide IgG autoantibody, and frequency of WT1-CTL in PB * This is evaluated at the interval ranging from 6 to 12 months.	—

Secondary

Measure	Time frame
Safety (Occurrence of SAE during the vaccination period) Clinical efficacy (Tumor regression during the vaccination period, OS, PFS)	—

Countries

Japan

Contacts

Public ContactYusuke Oji

Osaka University Graduate School of Medicine Dept. Cancer Immunotherapy

clinical-trial@cit.med.osaka-u.ac.jp06-6879-3677

Outcome results

None listed

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