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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035020
Receipt No. R000039932
Scientific Title Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.
Date of disclosure of the study information 2018/11/27
Last modified on 2018/11/27

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Basic information
Public title Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.
Acronym Vaccination with neoantigen-loaded DCs
Scientific Title Safety assessment of neoantigen peptides-loaded dendritic cell vaccination therapy.
Scientific Title:Acronym Vaccination with neoantigen-loaded DCs
Region
Japan

Condition
Condition Malignant tumor (except leukemia)
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Nephrology Neurology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Pediatrics Ophthalmology Dermatology
Oto-rhino-laryngology Urology Oral surgery
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Safety
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
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
Interventions/Control_1 neoantigen peptides-loaded (autologous) dendritic cells
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
12 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria A patient must:

- have ECOG Performance Status of 0, 1 and 2.

- maintain adequate function of key organs when the eligibility is confirmed, in particular:

1. haemoglobin 8.0 g/dl or more
2. platelet 50.000 /mm3 or more
3. total bilirubin 3 x ULN or more
4. AST/ALT 3 x ULN or less
5. creatinine 3 x ULN or less

- provide written consent for genetic analysis of tumor sample; neoantigen-screening analysis, and for treatment of those neoantigens-loaded DC vaccination.

- have a proper mental condition and an ability to recognize the object and contents of the study when informed consent is obtained.


Key exclusion criteria A patient must not:

- be impossible to obtain blood sample by Leukapeheresis.

- be positive in HIV antibody test.

- have active auto-immune disorder.

- have serious underlying disease.

- be pregnant (including pregnancy seeker)

- be judged ineligibles by clinician in this trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishi Tanigawa
Organization Bio-Thera Kai,Non-profit medicalcorporation
Division name Bio-Thera Clinic
Zip code
Address 5-6-12 Shinjyuku, Sinjyukuku, Tokyo 1600055 Japan
TEL 03-5919-1762
Email tanigawa@bio-c.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunobu Kobayashi
Organization Bio-Thera Kai,Non-profit medicalcorporation
Division name Bio-Thera Clinic
Zip code
Address 5-6-12 Shinjyuku, Sinjyukuku, Tokyo 1600055 Japan
TEL 03-5919-1762
Homepage URL
Email ykobayashi@bio-c.jp

Sponsor
Institute Bio-Thera Clinic
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 27 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039932

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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