UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038411