UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035998
Receipt No. R000038329
Scientific Title Manufacturing process study of Chimeric antigen receptor-T (CAR-T) cell therapy for solid cancer using healthy volunteer's samples
Date of disclosure of the study information 2019/02/25
Last modified on 2019/08/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Manufacturing process study of Chimeric antigen receptor-T (CAR-T) cell therapy for solid cancer using healthy volunteer's samples
Acronym Manufacturing process study of Chimeric antigen receptor-T (CAR-T) cell therapy for solid cancer using healthy volunteer's samples
Scientific Title Manufacturing process study of Chimeric antigen receptor-T (CAR-T) cell therapy for solid cancer using healthy volunteer's samples
Scientific Title:Acronym Manufacturing process study of Chimeric antigen receptor-T (CAR-T) cell therapy for solid cancer using healthy volunteer's samples
Region
Japan

Condition
Condition solid tumor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determination of cell condition for CAR-T cell therapy development against solid tumor
Basic objectives2 Others
Basic objectives -Others Determining cell condition for CAR-T cell therapy using healthy volunteer's leukocytes
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes None
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
65 years-old >
Gender Male
Key inclusion criteria healthy male
Body Weight >50kg
BMI 18.5~24.9
Hb >12.0/dL
Key exclusion criteria Subject who are entering or no more than 4 months after entered, or scheduled to enter other clinical research
Subject who were drawn blood more than 1200 mL within a year
Subject who donated whole blood more than 400mL within 12 weeks of IC
Subject who donated whole blood more than 200mL within 4 weeks of IC
Subject who donated whole blood component within 2 weeks of IC
White blood cell < 4000/uL at screening
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Hasunuma
Organization Kitasato University Kitasato Institute Hospital
Division name Department of Research
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo
TEL 03-5791-6350
Email t-hasu@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Hasunuma
Organization Kitasato University Kitasato Institute Hospital
Division name Department of Research
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo
TEL 03-5791-6350
Homepage URL
Email t-hasu@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 02 Month 25 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
2018 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 02 Month 25 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.