acute myelogenous leukemia, myelodysplastic syndrome
Conditions
Interventions
# 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 lymph
Sponsors
Mie University, Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed as either of the followings; a) acute myelogenous leukemia, relapsed or resistent to primary therapy, including atypical leukemia and transformed from myelodysplastic syndrome b) therapy-resistent myelodysplastic syndrome, not indicated for hematopoietic stem cell transplant 2. HLA-A*24:02-positive 3. PCR-confirmed WT1-antigen expression on leukemic or MDS cells 4. Performance status(ECOG) 0 to 2 5. Aged 20 years or more 6. Full recovery after the previous therapy 7. Normal major organ function, and meeting the criteria below # Serum total bilirubin within three times of upper normal level # AST(GOT)/ALT(GPT) within three times of upper normal level # Serum creatinine within three times of upper normal level # left ventricular ejection fraction of 55% or more # Arterial oxygen saturation of 94% or more 8. Having written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| # Occurence of adverse events # Changes of laboratory data # RCR(replication competent retrovirus) excretion # Clonal changes of TCR-gene transduced T lymphocytes | — |
Countries
Japan
Contacts
Public ContactShinichi Kageyama
Mie University Graduate School of Medicine Department of Immuno-Gene Therapy
Outcome results
None listed