UMIN-CTR Clinical Trial

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 Obsterics 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
Last 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
Email	kamigaki@j-immunother.com

Public contact
1st 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
Email	citeg@j-immunother.com

Sponsor
Institute	KOUSHIKAI,Non-profitmedicalcorporation
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032907