WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome

UMIN ID: UMIN000011519

Registered date:19/08/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: acute myelogenous leukemia, myelodysplastic syndrome
• Date of first enrollment: 2013/08/19
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

# WT1-TCR gene transduced lymphocyte transfer two doses of 2x10*8 cells (day0, day28) # WT1 peptide vaccination two SQ injections of 300mcg each (day 30, day44)
# WT1-TCR gene transduced lymphocyte transfer two doses of 1x10*9 cells (day0, day28) # WT1 peptide vaccination two SQ injections of 300mcg each (day 30, day44)
# WT1-TCR gene transduced lymphocyte transfer two doses of 5x10*9 cells (day0, day28) # WT1 peptide vaccination two SQ injections of 300mcg each (day 30, day44)

Outcome(s)

• Primary Outcome: # Occurence of adverse events # Changes of laboratory data # RCR(replication competent retrovirus) excretion # Clonal changes of TCR-gene transduced T lymphocytes

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: Mie University, Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
• Secondary Sponsor: Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
• Source(s) of Monetary Support: Mie University,Ehime University, Fujita Health University, Nagoya University(MEXT, Japan), and Takara Bio Inc.