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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048076
Receipt No. R000054796
Scientific Title Development of novel immunotherapy using NKT cells for malignant solid tumors in children
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/16

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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

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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