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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032981
Receipt No. R000037510
Scientific Title A clinical study on the safety of dendritic cell vaccine pulsed with neoantigen peptides for malignant tumor.
Date of disclosure of the study information 2018/08/31
Last modified on 2019/07/29

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Basic information
Public title A clinical study on the safety of dendritic cell vaccine pulsed with neoantigen peptides for malignant tumor.
Acronym A clinical study on the safety of dendritic cell vaccine pulsed with neoantigen peptides for malignant tumor.
Scientific Title A clinical study on the safety of dendritic cell vaccine pulsed with neoantigen peptides for malignant tumor.
Scientific Title:Acronym A clinical study on the safety of dendritic cell vaccine pulsed with neoantigen peptides for malignant tumor.
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Urology Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims at evaluating the safety of dendritic cell vaccine pulsed with neoantigen peptides that are selected among the predicted neantigens in patients with having a successful DNA/RNA extraction.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes Efficacy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine Maneuver
Interventions/Control_1 Dendritic cell vaccine therapy pulsed with neoantigen peptides.
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 A patient MUST:
1)Be diagnosed with malignant tumor by imaging findings or pathological or cytological study.
2)Have a successful genetic analysis of tumor sample at Seta Clinic Group.
3)Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
4)Be 20 years of age or older.
5)Visit outpatient department on schedule.
6)Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
7)Provide written consent to participate this study.
Key exclusion criteria A patient MUST NOT:
1)Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia.
2)Have a history of a serious drug allergy.
3)Have a positive result of HIV antibody.
4)Have a serious cardiac disorder.
5)Have an active autoimmune disorder.
6)Have a concurrent cancer.
7)Have an infectious disorder that is difficult to control.
8)Be a female who is pregnant, lactating, or with a possibility of pregnancy.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rishu Takimoto
Organization KOUSHIKAI,Non-profitmedicalcorporation
Division name Seta Clinic Tokyo
Zip code
Address 3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL 03-5280-0086
Email takimoto@j-immunother.com

Public contact
Name of contact person
1st name
Middle name
Last name Eri Oguma
Organization KOUSHIKAI,Non-profitmedicalcorporation
Division name Center for Clinical Trials and Research
Zip code
Address 3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL 03-5244-5751
Homepage URL
Email citeg@j-immunother.com

Sponsor
Institute KOUSHIKAI,Non-profitmedicalcorporation
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 瀬田クリニック東京(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 28 Day
Date of IRB
2018 Year 05 Month 23 Day
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
2020 Year 08 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The costs associated with several treatmens and examinations in this study shall be borne by each patient.

Management information
Registered date
2018 Year 06 Month 14 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037510

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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