UMIN-CTR Clinical Trial

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