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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032306
Receipt No. R000036658
Scientific Title Correlative observational study of phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor
Date of disclosure of the study information 2018/04/19
Last modified on 2018/04/18

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Basic information
Public title Correlative observational study of phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor
Acronym Correlative observational study of RK-NKT study
Scientific Title Correlative observational study of phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor
Scientific Title:Acronym Correlative observational study of RK-NKT study
Region
Japan

Condition
Condition Advanced or relapsed solid tumor
Classification by specialty
Pneumology Obsterics and gynecology Dermatology
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the prognosis and the change in immunological function of patients who have been administered the study drug or RK-163 pulsed autologous CD14 positive cells (RK-CD14MO) at least once during its phase I trial, and assess the long-term efficacy and safety of the product.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-Free Survival
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who meet all of the criteria below are eligible to participate in the study.
1) Patients who have received at least one dose of RK-CD14MO on RK-NKT study (KCTR-D011 study)
2) Patients who do not have anemia (as defined by Hb<9.0g/dL) at the time of enrollment
3) Patients who can give written informed consent to participate in the study
Key exclusion criteria Any patient that the PI/sub-PI deems ineligible to enroll in the study will be excluded from the study.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenzo Soejima
Organization Keio University Hospital
Division name Clinical and Translational Research Center, Translational Research Division
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email ksoejima@cpnet.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Matsuki
Organization Keio University Hospital
Division name Clinical and Translational Research Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email eri@keio.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 04 Month 19 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
2017 Year 12 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study will perform the following observations.
1. Long-term survival follow-up including overall survival and progression-free survival
2. Evaluation of change in peripheral blood immunological cell population and expression of immune-related genes
3. Identification of tumor antigen from previously biopsied specimens, and HLA and KIR subtype analysis to create tumor antigen specific HLA restricted tetramer to asses for change in tumor antigen-specific immune cell population
4. Identification of change in tumor antigen-specific immune cell population using specimens obtained during RK-NKT study
5. Evaluation of association between survival and immunological cell population change and HLA/KIR mismatch information

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036658

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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