UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033711 |
|---|---|
| Receipt number | 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 | 2022/08/12 10:59:06 |
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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 | Obstetrics 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
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
kageyama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Immuno-Gene Therapy, Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
not available
Publication of results
Unpublished
Result
URL related to results and publications
not available
Number of participants that the trial has enrolled
10
Results
The clinical data were analyzed in 10 patients. The safety in cohort 2 was confirmed.
Results date posted
| 2022 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
10 cases with refractory solid tumors were enrolled.
Participant flow
3 cases were allocated to cohort 1. 6 cases were to cohort 2. 1 case was to cohort 3.
Adverse events
One patient developed a grade 3 lung injury. Other adverse events were less than or equal to grade 2.
Outcome measures
Adverse events, Proliferative retrovirus excretion, Cell clonality by LAM-PCR, Kinetics of the infused cells
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038411
