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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033711
Receipt No. R000038411
Scientific Title Exploratory study of prediction marker for efficacy and safety of TBI-1201
Date of disclosure of the study information 2018/09/10
Last modified on 2020/02/09

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Basic information
Public title Exploratory study of prediction marker for efficacy and safety of TBI-1201
Acronym Exploratory study of TBI-1201
Scientific Title Exploratory study of prediction marker for efficacy and safety of TBI-1201
Scientific Title:Acronym Exploratory study of TBI-1201
Region
Japan

Condition
Condition Refractory solid tumor
Classification by specialty
Medicine in general Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Obsterics and gynecology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exploratory study on predictive factors for efficacy and safety of investigational drugs, TBI-1201 and preconditioning agent
(TBI-1201:MAGE-A4/TCR gene transduced T cell)
Basic objectives2 Others
Basic objectives -Others Basic study on predictive factors for efficacy and safety of investigational drugs, TBI-1201 and preconditioning agent
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cytokine analysis
Immune response analysis
Image diagnosis data
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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 Having enrolled to TBI-1201 clinical trial
Key exclusion criteria Not having enrolled to TBI-1201 clinical trial
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Kageyama
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie, Japan
TEL 059-231-5684
Email kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Kageyama
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Zip code 514-8507
Address 2-174, Edobashi, Tsu, Mie, Japan
TEL 059-231-5684
Homepage URL
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Immuno-Gene Therapy, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Funding under the agreement between Mie University and Takara Bio Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional of Review Board in Mie University Hospital
Address 2-174, Ebobashi, Tsu, Mie 514-8507 Japan
Tel 059-232-1111
Email s-kenkyu@mo.medic.mie-u.ac.jp

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 研究協力(研究試料提供) 名古屋医療センター(愛知県)、愛知医科大学(愛知県)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 10 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 09 Day
Date of IRB
2019 Year 01 Month 11 Day
Anticipated trial start date
2019 Year 01 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2020 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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