UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010729 |
|---|---|
| Receipt number | R000011921 |
| Scientific Title | Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning for therapy-resistant esophageal cancer |
| Date of disclosure of the study information | 2013/05/15 |
| Last modified on | 2015/09/21 17:18:04 |
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Basic information
Public title
Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning for therapy-resistant esophageal cancer
Acronym
Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning
Scientific Title
Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning for therapy-resistant esophageal cancer
Scientific Title:Acronym
Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene following lymphodepleting conditioning
Region
| Japan |
Condition
Condition
Therapy-resistant esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety, kinetics and clinical responses after trasnfer of autologous lymphocytes tranduced with TCR-alpha/beta gene recognizing MAGE-A4-peptide
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
# Safety; adverse events, including laboratory data and replication competent retrovirus(RCR)/linear amplification mediated-PCR(LAM-PCR)
Key secondary outcomes
# Kinetics and tumor infiltration of TCR/gene-transduced lymphocytes
# Tumor-specific immune responses
# Tumor shrinkage
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
First cohort; three patinets
1.Cyclophosphamide
400mg/m*2 x3days IV
2.TCR-gene-transduced autologous lymphocytes infusion
1x10*9 cells, single dose, IV
Interventions/Control_2
Second cohort; three patinets
1.Cyclophosphamide
400mg/m*2 x3days IV
2.TCR-gene-transduced autologous lymphocytes infusion
5x10*9 cells, single dose
Interventions/Control_3
Third cohort; three patinets
1.Cyclophosphamide
500mg/m*2 x3days IV
2.TCR-gene-transduced autologous lymphocytes infusion
5x10*9 cells, single dose
Interventions/Control_4
Fourth cohort; three patinets
1.Cyclophosphamide
600mg/m*2 x3days IV
2.TCR-gene-transduced autologous lymphocytes infusion
5x10*9 cells, single dose
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically-confirmed malignant esophageal tumor
2.Therapy-resistant cancer, including chemotherapy and radiotherapy, with clinical stage III or IV, recurrent, and metastatic disease
3.HLA-A2402-positive
4.PCR or immunohistochemistry-confirmed MAGE-A4-antigen expression of tumor cells
5.Having measurable tumor for assessing clinical responses
6.Performance status(ECOG) 0 to 1]
7.Aged 20 to 75 years
8.Recovery lasting after the previous therapy, including surgery, chemotherapy and radiotherapy
9.At least four-month life expectancy
10.Normal major organ function, and meeting the criteria below
# White cell counts 3,000/uL or more
# Neutrophils 1,500/uL or more
# Hemoglobin 8.0 g/dL or more
# Platelets 100,000/uL or more.
# Serum total bilirubin 2.0mg/dL or less
# AST(GOT)/ALT(GPT) 150IU/dL or less
# Serum creatinine 2.0mg/dL or less
# Aterial oxygen pressure 70 torr or more, or oxygen saturation 94% or more
11.Having written informed consent
Key exclusion criteria
1.Having 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
# Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL
Thrombosis tendency
2.History of serious hypersensitivity
3.Positive for HBs Ag, HCV Ab, HIV Ab, or HTLV-I Ab
4. Unctrolled pleural effusion, ascites, or pericardial effusion
5.Uncontrolled CNS metastasis
6.Systemic corticostoroid or immuno-suppressive therapy
7.Probable occurence of severe side-effects induced by cyclophosphamide
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 weeks from the previous enrollment to clinical trials
11.Inappropriate for study entry judged by an attending physician.
Target sample size
12
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
kageyama@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
kageyama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
TAKARA BIO INC.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2015 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011921
