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

JRCT ID: jRCT2043210077

Registered date:05/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: MAGE A4-positive and HLA-A*02:01-positive unresectable advanced or recurrent solid cancer
• Date of first enrollment: 01/11/2021
• Target sample size: 6
• Study type: Interventional

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)

Outcome(s)

• Primary Outcome: Safety and tolerability
• Secondary Outcome: Efficacy (ORR, DCR, best overall response, PFS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ishihara Mikiya
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development