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A safety study of combined immunotherapy for glioblastoma

A safety study of combined immunotherapy for glioblastoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTc031230593
Enrollment
3
Registered
2024-01-26
Start date
2025-01-28
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

Interventions

blood collection for cell culture and tests. Administration of therapeutic cells(neoantigen DC) 6 times and cells(2DG-CTL ) 6 times

Sponsors

Kondo Akihide
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Diagnosed with IDH-unmutated glioblastoma. (2) Have a successful genetic analysis of tumor sample. (3)Be at score 70 or over of Karnofsky Performance Status (KPS). (4)Be expected to survive for 3months or longer after initiation of the study therapy. (5)Be at age 20 or older. (6)Visit outpatient department. (7)Have an adequate function of liver, kidney, and bone marrow when eligibility is confirmed. (8)Provide written consent to participate this study.

Exclusion criteria

Exclusion criteria: (1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia. (2)Have a history of a serious drug allergy. (3)Have a positive result of HIV or HTLV-1 antibody test. (4)Have a serious cardiac disorder. (5)Have an active autoimmune disorder. (6)Have a cancer other than glioma. (7)Have an infectious disorder that is difficult to control. (8) Patients with postoperative recurrence after standard treatment (surgery, chemoradiation). (9)Be a female who is pregnant. (10)A patient who is judged as inadequate for enrolment by doctors is excluded

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Efficacy, Immunological response, Quality of therapeutic cells, Quality of life

Countries

Japan

Contacts

Public ContactTakashi Kamigaki

Juntendo University

seta@juntendo.ac.jp+81-3-6801-5605

Outcome results

None listed

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