Open-labeled, non-randomized, single institute study to evaluate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with advanced malignancies.

Open-labeled, non-randomized, single institute study to evaluate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with advanced malignancies. - Dendritic cell vaccination for patients with advanced malignancies

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027279

Enrollment

200

Registered

2017-05-09

Start date

2009-04-01

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

Patients with advanced malignancies

Interventions

Patients are injected intradermally at axilla or inguinal region with dendritic cells pulsed with artificial antigens or tumor lysate (approximately 1x107). At the same time, OK432 (0.5-3KE) is inject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced or relapsed malignancies 2. Having evaluable disease by RECIST criteria 3. Performance Status; 0-2 4. Survival period is expected more than 4 months 5. Meet the following criteria for organ functions 1) WBC more than 2,500/microliter, Hemoglobin more than 9.0 g/dl, Platelet more than 90,000/microliter 2) Serum AST/ALT less than 2.5 folds of the upper normal limit 3) Serum bilirubin less than1.5 folds of the upper normal limit 4) Serum Albumin more than 3.0g/dl 5) Serum creatinine within normal limitation 6. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells. 7. HLA-A*2402, 0201 or 0206 positive (WT1 DC) 8. Informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1. There is deep-seated active infection. 2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered inappropriate for the trial. 4. There are other malignancies. 5. Pregnant or lactating woman. 6. Past history of severe drug allergy. 7. There is severe psychiatric disease. 8. The patient is considered inappropriate for the trial by a responsible doctor.

Design outcomes

Primary

Measure	Time frame
Adverse events and Efficacy	—

Secondary

Measure	Time frame
Immunological response,Progression free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactIkumi Tkahashi

Sapporo Hokuyu Hospital Cellular Immunotherapy Center

i.yamada0414@hokuyu-aoth.org011-865-0111

Outcome results

None listed

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