UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015733 |
|---|---|
| Receipt number | R000018245 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2017/05/24 19:24:11 |
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Basic information
Public title
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
Acronym
Safety of cell immunotherapy for refractory malignant tumor using CA-MED-NK001 cells
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | 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
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL
092-642-5228
akashi@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadafumi Iino ( or Shigeo Takaishi ) |
Organization
Center for Advanced Medical Innovation, Kyushu University
Division name
Division of Advanced Cell Therapy
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city, Fukuoka prefecture, Japan
TEL
092-642-4258
Homepage URL
takaishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Center for Advanced Medical Innovation, Kyushu University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
This trial has been terminated due to the difficulties of the recruitment of condition-matched subjects after the entry of four patients.
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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018245
