MAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer
Conditions
Interventions
Fludarabine (20 mg/m^2 for 3 days)
Cyclophosphamide (750 mg/m^2 for 2 days)
MU-MA402C (2x10^8 or 2x10^9 cells)
Sponsors
Ishihara Mikiya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Solid cancer confirmed histologically or cytologically 2)Unresectable advanced or recurrent disease 3)HLA-A*02:01 positive 4)MAGE A4-expression in tumor by immunohistochemistry 5)Patients who are incurable after at least 1 regimen of standard systemic therapy for advanced or recurrent disease 6)Ability to understand the study content and to give a written consent at free will 7)Legal adult on informed consent 8)ECOG PS: 0-1 9)No severe damage on major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the prescribed lab value criteria 10)Well-managed nutritionally
Exclusion criteria
Exclusion criteria: 1)The following complications are excluded from the study; unstable angina, cardiac infarction or heart failure, uncontrolled diabetes or hypertension, active infection, obvious interstitial pneumonia or lung fibrosis by chest X-ray, active autoimmune disease requiring steroids or immunosuppressive therapy 2)Serious hypersensitivity 3)Tumor cell invasion into CNS 4)Active multiple cancer 5)Positive for HBs antigen or HBV-DNA observed in serum, or positive for HCV antibody and HCV-RNA observed in serum 6)Positive for antibodies against HIV or HTLV-1 7)LVEF < 50% 8)SpO2 < 94% 9)History of serious hypersensitivity reactions to bovine or murine derived substances 10)History of hypersensitivity reaction to drugs used in this study 11)During chemotherapy or radiotherapy 12)Psycological disorder or drug dependency which may have impact on the consent 13)Patients who cannot agree to practice the adequate birth control 14)Pregnant females, lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (ORR, DCR, best overall response, PFS) | — |
Contacts
Public ContactTatsushi Goto
FiveRings Co.,Ltd.
Outcome results
None listed