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A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma

A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma - A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032147
Enrollment
5
Registered
2018-04-09
Start date
2018-04-09
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

glioma

Interventions

alpha beta T cell therapy Temozolomide

Sponsors

Juntendo University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Diagnosed with IDH-unmutated high-grade glioma 2) Receive Temozolomide maintenance therapy after standard therapy including surgery, radiotherapy, and chemotherapy with Temozolomide 3) Be at score 70 or over of Karnofsky Performance Status (KPS) 4) Be expected to survive for 2months 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) Be a female who is pregnant

Design outcomes

Primary

MeasureTime frame
Efficacy

Secondary

MeasureTime frame
The quality of life for patients

Countries

Japan

Contacts

Public ContactAkihide Kondo

Juntendo University Hospital Neurosurgery

knd-aki@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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