Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning for therapy-resistant esophageal cancer
- Conditions
- Therapy-resistant esophageal cancer
- Registration Number
- JPRN-UMIN000010729
- Lead Sponsor
- Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
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.Positive for HBs Ag, HCV Ab, HIV Ab, or HTLV-I Ab 4. Unctrolled pleural effusion, ascites, or pericardial effusion 5.Uncontrolled CNS metastasis 6.Systemic corticostoroid or immuno-suppressive therapy 7.Probable occurence of severe side-effects induced by cyclophosphamide 8.Mental illness or drug dependency affecting informed consent 9.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm 10. Lasting less than four weeks from the previous enrollment to clinical trials 11.Inappropriate for study entry judged by an attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method # Safety; adverse events, including laboratory data and replication competent retrovirus(RCR)/linear amplification mediated-PCR(LAM-PCR)
- Secondary Outcome Measures
Name Time Method # Kinetics and tumor infiltration of TCR/gene-transduced lymphocytes # Tumor-specific immune responses # Tumor shrinkage