UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032306 |
|---|---|
| Receipt number | 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 | 2020/10/07 20:32:38 |
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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 | Obstetrics 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
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
eri@keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 18 | Day |
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
| 2020 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036658
