UMIN-CTR Clinical Trial

Basic information
Public title	Adoptive immunotherapy using zoledronate-expanded autologous gamma/delta T cells for patients with non-small cell lung cancer refractory to standard treatment.
Acronym	Zoledronate-expanded autologous gamma/delta T cell therapy for NSCLC
Scientific Title	Adoptive immunotherapy using zoledronate-expanded autologous gamma/delta T cells for patients with non-small cell lung cancer refractory to standard treatment.
Scientific Title:Acronym	Zoledronate-expanded autologous gamma/delta T cell therapy for NSCLC
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of autologous gamma/delta T cell transfer therapy for patients with non-small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Safety Efficacy: - Antitumor effect; - Overall survival; - Improvement of tumor-related markers; - QOL score.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Autologous gamma/delta T cells are injected on day0, day14, day28, day42, day56, day70.
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	Non-small cell lung cancer patients who meet the following criteria: - Refractory to standard treatment; - Life-expectancy more than 6 months; - 20 years or more; - Performance status 0-1; - No serious abnormality in bone marrow, liver and/or renal functions.
Key exclusion criteria	Patients who have: - Uncontrolled infections; - Active autoimmune diseases; - Serious cardiac disease; - Other cancers; - Received continuous systemic steroids; - Pregnant, to be pregnant, or nursing mothers; - Principle investigator or co-investigator judged to be inappropriate to participate in this study.
Target sample size	85

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Nakajima
Organization	The University of Tokyo Hospital
Division name	Department of Cardiothoracic surgery
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	03-3815-5411
Email	immunotherapy-admin@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Kakimi
Organization	The University of Tokyo Hospital
Division name	Department of Immunotherapeutics
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	03-5805-3163
Homepage URL
Email	immunotherapy-admin@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	東京大学医学部附属病院（東京都）、慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 08 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	2011 Year 07 Month 28 Day
Date of IRB	2011 Year 07 Month 28 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2019 Year 04 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 08 Month 08 Day
Last modified on	2019 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007250