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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031684
Receipt No. R000036186
Scientific Title 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 2018/03/12
Last modified on 2018/03/26

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Basic information
Public title Phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor
Acronym Phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor.
(RK-NKT Study)
Scientific Title 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 Phase 1 study of RK-163 pulsed human autologous CD14-positive cells (RK-CD14MO) for patients with advanced or relapsed solid tumor.
(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 NO

Objectives
Narrative objectives1 Defining dose limiting toxicity (DLT) of RK-CO14MO
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Proportion expressing DLT by Day57 of treatment
Key secondary outcomes Safety and Efficacy at Day57 of treatment

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
Other
Interventions/Control_1 RK-CD14MO will be given at Day1 and 22 of treatment
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 1) patients with histologically or cytologically documented and definitely diagnosed solid tumor
2)patients with advanced or recurrent solid tumors who are refractory to standard treatment or who have no defined standard treatment
3) Age 20 to 74 years-old at the time of consent
4)ECOG PS 0 or 1
5) Harbors one or more lesions that are evaluable by RECIST ver1.1
6)patients with sustained major organ function defined as:

7)monocyte count over 200/mm3
8)independent of blood transfusion or growth factor support within 2 weeks of obtaining consent
9)patients who are expected to live longer than 3 months at the time of consent
10) Patients who are more than 3 weeks out of initiation of prior antitumor treatment, and who have no residual side effects from that treatment
11) Patients who can give written informed consent
Key exclusion criteria 1) Patients with symptomatic central nervous system invasion
2) patients with any kind of psychiatric disorder that compromises the ability of the subject to comply with study procedures and/or compromises the ability of the subject to give written informed consent
3)HIV or HTLV-1 antibody positive
4)HBsAg, HBcAb, HCVAb positive
5) history of autoimmune disease other than thyroid dysfunction caused by immune checkpoint inhibitors
6) history of hematological malignancies
7)immune checkpoint inhibitors within 2 months of consent
8)known severe sensitivity to human serum albumin preparation
9)known severe cardiac dysfunction or cardiovascular disease defined as, NYHA class III or IV, severe cardiovascular disease within 6 months of consent
10)patient with
-uncontrolled diabetes
-active infectious disease
-uncontrolled blood coagulation disorders
-uncontrolled hypertension
11)known history of severe infectious disease within 4 weeks of initial consent
12) history of or existing interstitial pneumonia or aspiration pneumonia
13)concurrent use of per oral of inhalation steroids
14)patient who are pregnant or breast-feeding, or expecting to be pregnant
15)patients with active tumor other than the current target tumor
16) Patients with ascites or pleural effusion requiring medical intervention such as drainage
17)no blood vessel adequate for cell collection
18)patients treated with other investigational agents within 2 months of consent
19)patients who are deemed ineligible by PI/Sub-PI
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
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan,160-8582
TEL 03-3353-1211
Email ksoejima@cpnet.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuji Tanosaki
Organization Keio University Hospital
Division name Center for Transfusion Medicne and Cell Therapy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan,160-8582
TEL 03-5363-3715
Homepage URL
Email rtanosak@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 Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Ambicion Co., Ltd.

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 03 Month 12 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 12 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036186

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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