NIPH Clinical Trials Search

JRCT ID: jRCT2043210077

Registered date:05/10/2021

Multi-institutional phase 1 clinical study to examine the safety and tolerability of MU-MA402C for MAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer
Date of first enrollment01/11/2021
Target sample size6
Countries of recruitment
Study typeInterventional
Intervention(s)Fludarabine (20 mg/m^2 for 3 days) Cyclophosphamide (750 mg/m^2 for 2 days) MU-MA402C (2x10^8 or 2x10^9 cells)


Primary OutcomeSafety and tolerability
Secondary OutcomeEfficacy (ORR, DCR, best overall response, PFS)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1)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
Exclude criteria1)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

Related Information


Public contact
Name Tatsushi Goto
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka Osaka Japan 530-0044
Telephone +81-6-6358-7110
Affiliation FiveRings Co.,Ltd.
Scientific contact
Name Mikiya Ishihara
Address 3-1-69 Otemae, Chuo-ku, Osaka 541-8567 Japan Osaka Japan 541-8567
Telephone +81-6-6945-1181
Affiliation Osaka International Cancer Institute