UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028756 |
|---|---|
| Receipt number | R000032907 |
| Scientific Title | An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors. |
| Date of disclosure of the study information | 2017/08/22 |
| Last modified on | 2019/03/27 22:27:03 |
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Basic information
Public title
An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.
Acronym
An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.
Scientific Title
An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.
Scientific Title:Acronym
An exploratory clinical study on the safety of combination therapy with effector cell therapy and immune checkpoint inhibitors.
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Vascular surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Pediatrics | Dermatology |
| Oto-rhino-laryngology | Urology | Radiology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims at evaluating the safety of combination with immune-cell therapy (Alpha beta T-cell therapy) and immune checkpoint inhibitors (Nivolumab) in patients with advanced recurrent solid cancer; moreover, the efficacy, immunological response and biomarker searching are secondarily evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy
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
| Medicine | Maneuver |
Interventions/Control_1
Alpha beta T-cell therapy
Nivolumab
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient MUST:
(1)Have enrolled in "Multicenter clinical study of immune-cell therapy in patients with malignant tumors" (UMIN ID: UMIN000019030).
(2)Have measurable lesions of tumors.
(3)Be 0 of PS score.
(4)Be confirmed in decrease in the number of lymphocytes in the test of cell surface marker by specified peripheral blood flow cytometry prior to initiating treatment.
(5)Obtain an undyed tissue section.
(6)Received Alpha beta T-cell therapy more than twice at Seta Clinic Group, and the last treatment has been within 12 months.
(7)Have adequate function of main organs (heart, lung, liver, kidney, and bone marrow) at the time of eligibility confirmation.
(8)Be expected to survive for more than 4 months from the time of eligibility confirmation.
(9)Obtain their doctor's consent about participation in this study.
(10)Have secured medical facilities that can hospitalize in case of emergency.
(11)Provide written consent to participate this study.
Key exclusion criteria
A patient MUST NOT:
(1)Have treated with immune checkpoint inhibitors.
(2)Be a female who is pregnant, lactating, or with a possibility of pregnancy.
(3)Be determined to be inappropriate by the doctor in charge.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kamigaki |
Organization
KOUSHIKAI,Non-profitmedicalcorporation
Division name
Center for Clinical Trials and Research
Zip code
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL
03-5244-5751
kamigaki@j-immunother.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Oguma |
Organization
KOUSHIKAI,Non-profitmedicalcorporation
Division name
Center for Clinical Trials and Research
Zip code
Address
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
TEL
03-5244-5751
Homepage URL
citeg@j-immunother.com
Sponsor or person
Institute
KOUSHIKAI,Non-profitmedicalcorporation
Institute
Department
Personal name
Funding Source
Organization
KOUSHIKAI,Non-profitmedicalcorporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seta Clinic Tokyo
Medinet Co.,Ltd.
Name of secondary funder(s)
Medinet Co.,Ltd.
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
瀬田クリニック東京（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The costs associated with several treatmens and examinations in this study
shall be borne by each patient.
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032907
