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Immunotherapy with fusions of glioma cells, glioma initiating cells, and dendritic cells for patients with malignant glioma

Phase 2
Recruiting
Conditions
Malignant glioma (Grade 3 or 4 glioma in the WHO criteria)
Registration Number
JPRN-UMIN000023806
Lead Sponsor
Jikei University School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1)A patient who has an allergy to biological medicines. 2)A patient who has a past or current history of autoimmune disease. 3)A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody. 4)A patient who has sever immune deficiency. 5)A patient who is administrated steroids for a long period, and is difficult to stop it. 6)A patient who has sever infectious disease. 7)A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification). 8)A patient who has sever heart disease (Class 3 or more in the NYHA). 9)A patient who has uncontrollable diabetes. 10)A pregnant or lactating patient. 11)A patient who is involved in other clinical trials.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2-year overall survival (OS) rate (a group of initially diagnosed grade 4 glioma) 3-year OS rate (a group of initially diagnosed grade 3 glioma) 1-year OS rate (a group of recurrent glioma)
Secondary Outcome Measures
NameTimeMethod
1-year progression free survival (PFS) rate (a group of initially diagnosed grade 4 glioma) 2-year PFS rate (a group of initially diagnosed grade 3 glioma) 6-month PFS rate (a group of recurrent glioma)
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