UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035998 |
|---|---|
| Receipt number | 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 | 2020/05/11 10:26:23 |
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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
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
t-hasu@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 03 | Day |
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
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038329
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
