Therapy-resistant esophageal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient who completed "adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene(UMIN000002395)" 2.adverse events whith grade 1 or 2 during the above study 3.Performance status(ECOG) 0 to 1 4.Having written informed consent
Exclusion criteria
Exclusion criteria: 1.Having following serious complications # Uncontrolled anigina pectoris, myocardial infarction, or heart failure # Uncontrolled diabetes mellitus or hytertention # Uncontrolled infection # X-ray-proven interstitial pneumonia or pulmonary fibrosis # Autoimmune disease # Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL Thrombosis tendency 2.History of serious hypersensitivity 3.Unctrolled pleural effusion, ascites, or pericardial effusion 4.Uncontrolled CNS metastasis 5.Systemic corticostoroid or immuno-suppressive therapy 6. Inappropriate for MAGE-A4 143-151 peptide administration, i.e. allergic to the peptide or adjuvant 7.Mental illness or drug dependency affecting informed consent 8.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm 9. Lasting less than four weeks from the previous enrollment to clinical trials 11.Inappropriate for study entry judged by an attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety immune reaction | — |
Countries
Japan
Contacts
Mie University Graduate School of Medicine Immuno-Gene Therapy