UMIN-CTR Clinical Trial

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 Rishu Middle name Last name Takimoto
Organization	KOUSHIKAI,Non-profitmedicalcorporation
Division name	Seta Clinic Tokyo
Zip code	101-0062
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 Eri Middle name Last name Oguma
Organization	KOUSHIKAI,Non-profitmedicalcorporation
Division name	Center for Clinical Trials and Research
Zip code	1010062
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	Seta Clinic Group Certified Committee for Regenerative Medicine
Address	3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
Tel	03-5244-5751
Email	ccrm@j-immunother.com

Secondary IDs
Secondary IDs	NO
Study ID_1	jRCTc030190213
Org. issuing International ID_1	jRCT (Japan Registry Clinical Trials)
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	Terminated
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. Transition to jRCT (Japan Registry Clinical Trials).

Management information
Registered date	2018 Year 06 Month 14 Day
Last modified on	2020 Year 03 Month 19 Day

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