UMIN-CTR Clinical Trial

Basic information
Public title	Development of novel immunotherapy using NKT cells for malignant solid tumors in children
Acronym	Development of novel immunotherapy using NKT cells for malignant solid tumors in children
Scientific Title	Development of novel immunotherapy using NKT cells for malignant solid tumors in children
Scientific Title:Acronym	Development of novel immunotherapy using NKT cells for malignant solid tumors in children
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to validate the efficacy of NKT cell-based immunotherapy for pediatric malignant solid tumors in vivo and in vitro.
Basic objectives2	Others
Basic objectives -Others	The goal of this study is the development of a new treatment for pediatric malignant solid tumors.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	None
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: Between 20 and 60 years old. 2) Healthy adults with no history of malignant tumors. 3) Those who acknowledge understanding the terms and conditions of this study, and sign study participant agreement of their own free will, after receiving sufficient explanation on participation in this study.
Key exclusion criteria	We exclude participants from whom it is difficult to collect blood (in cases where participants' conditions are significantly poor, or it is difficult to collect blood from participants technically).
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shinichiro Middle name Last name Motohashi
Organization	Graduate school of Medicine, Chiba University
Division name	Department of Medical Immunology
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Email	motohashi@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Motohashi
Organization	Graduate school of Medicine, Chiba University
Division name	Department of Medical Immunology
Zip code	2608670
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	motohashi@faculty.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	None
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	Clinical Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel	043-222-7171
Email	m_maekawa@chiba-u.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

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 17 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	Open public recruiting
Date of protocol fixation	2021 Year 02 Month 09 Day
Date of IRB	2021 Year 04 Month 09 Day
Anticipated trial start date	2021 Year 04 Month 10 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, approximately 30 mL of blood is collected from healthy adult volunteers and peripheral blood mononuclear cells are isolated for use in the experiment.

Management information
Registered date	2022 Year 06 Month 16 Day
Last modified on	2022 Year 06 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054796