GD2-positive solid tumors
Conditions
Interventions
Pretreatment
1) Fludarabine : once daily, 30 mg/m^2, for 3 days
2) Cyclophosphamide : once daily, 500 mg/m^2, for 2 days
MU-G2GL01
Cohort A : 6.0 x 10^8 cells/body
Cohort B : 3.0 x 10^8 cells/body
Sponsors
Kageyama Shinichi
Fujiwara Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Solid tumor that are GD2-positive by immunohistochemistry. 2) Metastasis or recurrence disease worsened after standard systemic therapy, or intolerance to standard systemic therapy before start of protol therapy. 3) ECOG Performance Status: 0 or 1 4) Weight: 30 kg or more
Exclusion criteria
Exclusion criteria: 1) The following complications are excluded from this study. - Unstable angina, myocardial infarction or heart failure - Uncontrolled diabetes mellitus - Active HBV infection, active HCV infection, HIV infection and other ucontrolled infections - Obvious interstitial pneumonia or lung fibrosis by scan - Autoimmune diseases and immune-related adverse events required steroids or immunosuppressive therapy 2) Active metastatic disease or cancerous meningitis in the central nervous system 3) Active multiple cancers 4) Left ventricular ejection fraction: less than 50% 5) SpO2: less than 94%. 6) History of serious allergy to any of the pre-treatment medications and medications for adverse event which are specified in the study protocol, or bovine or murine derived substances 7) Pregnant females or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability: Tolerability was evaluated for each cohort based on the frequency of occurrence of DLT. Safety: Evaluate the type, frequency, and severity of adverse events and their causal relationship to the investigational product or drug, as well as the nature of the failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (best overall response, response rate at day 56, disease control rate at day 56, progression-free survival) based of RECIST ver1.1 and iRECIST | — |
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed