NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000011519

Registered date:19/08/2013

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedacute myelogenous leukemia, myelodysplastic syndrome
Date of first enrollment2013/08/19
Target sample size9
Countries of recruitmentJapan
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1. 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
Exclude criteria1.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

Contact

public contact
Name Shinichi Kageyama
Address 2-174, Edobashi, Tsu, Mie 514-8507, Japan Japan
Telephone 059-231-5187
E-mail kageyama@clin.medic.mie-u.ac.jp
Affiliation Mie University Graduate School of Medicine Department of Immuno-Gene Therapy
scientific contact
Name Hiroshi Shiku
Address 2-174, Edobashi, Tsu, Mie 514-8507, Japan Japan
Telephone 059-231-5187
E-mail shiku@clin.medic.mie-u.ac.jp
Affiliation Mie University Graduate School of Medicine Department of Immuno-Gene Therapy