UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011519 |
|---|---|
| Receipt number | R000012910 |
| Scientific Title | WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome |
| Date of disclosure of the study information | 2013/08/19 |
| Last modified on | 2018/12/18 08:42:13 |
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Basic information
Public title
WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
Acronym
siTCR-WT1-AML/MDS gene therapy
Scientific Title
WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
Scientific Title:Acronym
siTCR-WT1-AML/MDS gene therapy
Region
| Japan |
Condition
Condition
acute myelogenous leukemia, myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of WT1-TCR gene transduced cell transfer and WT1 peptide vaccine
Basic objectives2
Others
Basic objectives -Others
# Cell kinetics of TCR-gene transducsed cells in peripheral blood
# Hematological effect, including molecular levels using PCR methods
# Immunological analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
# Occurence of adverse events
# Changes of laboratory data
# RCR(replication competent retrovirus) excretion
# Clonal changes of TCR-gene transduced T lymphocytes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
# 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)
Interventions/Control_2
# 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)
Interventions/Control_3
# 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)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Shiku |
Organization
Mie University Graduate School of Medicine
Division name
Department of Immuno-Gene Therapy
Zip code
Address
2-174, Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5187
shiku@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Kageyama |
Organization
Mie University Graduate School of Medicine
Division name
Department of Immuno-Gene Therapy
Zip code
Address
2-174, Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5187
Homepage URL
http://www.shikuken.jp/
kageyama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
Institute
Department
Personal name
Funding Source
Organization
Mie University,Ehime University, Fujita Health University, Nagoya University(MEXT, Japan), and Takara Bio Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
三重大学医学部附属病院（三重県）、愛媛大学医学部附属病院（愛媛県）、藤田保健衛生大学病院（愛知県）、名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.bloodjournal.org/content/130/18/1985.long?sso-checked=true
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012910
