UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Acronym	A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Scientific Title	A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Scientific Title:Acronym	A clinical study on the safety of immune-cell therapy combined with standard therapy for high-grade glioma
Region	Japan

Condition
Condition	glioma
Classification by specialty	Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purposes of this study is to evaluate the efficacy of combination with immune-cell therapy (alpha betaT-cell therapy) and maintenance chemotherapy (Temozolomide) for patients with IDH-unmutated high-grade glioma that is amenable to surgery, radiotherapy, and Temozolomide, and the safety and immunological responses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Efficacy
Key secondary outcomes	The quality of life for patients

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	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	alpha beta T cell therapy Temozolomide
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	1) Diagnosed with IDH-unmutated high-grade glioma 2) Receive Temozolomide maintenance therapy after standard therapy including surgery, radiotherapy, and chemotherapy with Temozolomide 3) Be at score 70 or over of Karnofsky Performance Status (KPS) 4) Be expected to survive for 2months or longer after initiation of the study therapy 5) Be at age 20 or older 6) Visit outpatient department 7) Have an adequate function of liver, kidney, and bone marrow when eligibility is confirmed 8) Provide written consent to participate this study
Key exclusion criteria	1) Be apparent from the clinical manifestation of pulmonary fibrosis or interstitial pneumonia 2) Have a history of a serious drug allergy 3) Have a positive result of HIV or HTLV-1 antibody test 4) Have a serious cardiac disorder 5) Have an active autoimmune disorder 6) Have a cancer other than glioma 7) Have an infectious disorder that is difficult to control 8) Be a female who is pregnant
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Akihide Middle name Last name Kondo
Organization	Juntendo University Hospital
Division name	Neurosurgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Email	knd-aki@juntendo.ac.jp

Public contact
Name of contact person	1st name Akihide Middle name Last name Kondo
Organization	Juntendo University Hospital
Division name	Neurosurgery
Zip code	113-8431
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	knd-aki@juntendo.ac.jp

Sponsor
Institute	Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board of Juntendo University Faculty of Medicine
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3176
Email	rinri@juntendo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTc030190246
Org. issuing International ID_1	jRCT (Japan Registry Clinical Trials)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	順天堂大学医学部付属順天堂医院（東京都） Juntendo University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 09 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	Terminated
Date of protocol fixation	2018 Year 03 Month 14 Day
Date of IRB	2017 Year 12 Month 12 Day
Anticipated trial start date	2018 Year 04 Month 09 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transition to jRCT (Japan Registry Clinical Trials).

Management information
Registered date	2018 Year 04 Month 07 Day
Last modified on	2020 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036671