WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
- Conditions
- acute myelogenous leukemia, myelodysplastic syndrome
- Registration Number
- JPRN-UMIN000011519
- Lead Sponsor
- Mie University, Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1.Having the 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 2. History of severe allergy 3. Either of HBV, HCV, HIV and HTLV-1 infection 4. Expected life splan of 4 months or less 5. Uncontrolled pleural effusion, ascites or pericardial effusion 6. CNS involvement affecting safety issues 7. Systemic corticostoroid (prednisolone of 0.5mg/kg/day or more), or immuno-suppressive therapy 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 months from the previous enrollment to clinical trials 11. Received allogeneic hematopoietic stem cell transplantation 12. Inappropriate for study entry judged by an attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method