UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of cell immunotherapy for refractory malignant tumor using natural killer cell-like effector cells (CA-MED-NK001) selectively amplified from autologous mononuclear cells in peripheral blood
Title of the study (Brief title)	Safety of cell immunotherapy for refractory malignant tumor using CA-MED-NK001 cells
Region	Japan

Condition
Condition	all classes of malignant tumors, after treatment with (or not applicable for) standard therapies for cancers
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of safety of cell immunotherapy using natural killer cell-like effector cells (CA-MED-NK001 cells) by dose titration method
Basic objectives2	Others
Basic objectives -Others	Evaluation of anti-tumor effects (response rate, duration, disease control rate, progression free survival etc) and immunological effects (immunological parameters, serum cytokine levels, immunological cell profiling in peripheral blood etc)
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Safety (Adverse events and their frequency, timing, duration and incidence rate)
Key secondary outcomes	Efficacy and immunological response

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	CA-MED-NK001 cells are intravenously administered almost every two weeks. Total six infusions will be performed. Dose (cell numbers) of each infusion will be defined as follows. (1) level one: five hundred millions (2) level two: one billion (3) level three: one billion or more.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients to be included would satisfy all of the following conditions: (1) pathologicaly diagonized as and informed with malignant tumors except the cases which are diagonized by only clinical data and imaging exams, then already performed with standard therapies. (2) after treatment with (or not applicable for) standard therapies (3) age at the entry into this study is not less than 20 years old (4) outward patient (5) ECOG Performance Status (PS):0--2 (6) satisfying following criteria in blood test: a) WBC: not less than 3.0x103/mm3, b) neutrofil: not less than 1.5x103/mm3, c) platelet: not less than 5.0x104/mm3, d) hemoglobin: not less than 8.5g/dL e) T-Bil:less than 1.5xN (N:maximum normal level), f) AST(GOT):less than 3xN, g) ALT(GPT):less than 3xN, h) S-Cr:not more than 1.5xN, (7) fully informed of the treatment of this study
Key exclusion criteria	Patients to be excluded would satisfy any of the following conditions: (1) pulmonary fibrosis and/or interstitial pneumonia (2) patients who have a history of severe drug allergy (3) serum positive for HBs antigen, HCV, HTLV-1 and/or HIV antibody (4) active autoimmune disease (5) patients who are taking steroids and/or immunosuprresive agents (6) double or more cancers (7) uncontrolable infectious disease (8) Patients to be or wishing for pregnancy, or breast-feeding (9) T cell- or NK cell-originated leukemia and/or lymphoma (10) heavy cardiological disease (11) Patientss who are regarded as inadequate for study enrollment by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Koichi Akashi
Organization	Department of Medicine and Biosystemic Science, Faculty of Medical Sciences, Kyushu University and Center for Advanced Medical Innovation, Kyushu University
Division name	Professor, Dupty Director
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL	092-642-5228
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	Tadafumi Iino ( or Shigeo Takaishi )
Organization	Center for Advanced Medical Innovation, Kyushu University
Division name	Division of Advanced Cell Therapy
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL	092-642-4258
Homepage URL
Email	takaishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Center for Advanced Medical Innovation, Kyushu University
Institute
Department

Funding Source
Organization	MEDINET Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Comprehensive Clinical Oncology, Faculty of Medical Sciences, Kyushu University
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	13-E19
Org. issuing International ID_1	Clinical Research Network Fukuoka
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学先端医療イノベーションセンター（福岡県） Center for Advanced Medical Innovation, Kyushu University (Fukuoka, Japan)

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 21 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This trial has been terminated due to the difficulties of the recruitment of condition-matched subjects after the entry of four patients.
Other related information

Management information
Registered date	2014 Year 11 Month 21 Day
Last modified on	2017 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018245