UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032981 |
|---|---|
| Receipt number | 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 | 2020/03/19 18:23:29 |
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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 |
| Obstetrics 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
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
citeg@j-immunother.com
Sponsor or person
Institute
KOUSHIKAI,Non-profitmedicalcorporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037510
