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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000336
Receipt No. R000000431
Scientific Title Clinical study on safety and efficacy of adoptive transfer of autologous gamma/delta T lymphocytes in patients with non-small cell lung cancer.
Date of disclosure of the study information 2006/03/01
Last modified on 2013/05/09

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Basic information
Public title Clinical study on safety and efficacy of adoptive transfer of autologous gamma/delta T lymphocytes in patients with non-small cell lung cancer.
Acronym Clinical study of gamma/delta T cell therapy for non-small cell lung cancer
Scientific Title Clinical study on safety and efficacy of adoptive transfer of autologous gamma/delta T lymphocytes in patients with non-small cell lung cancer.
Scientific Title:Acronym Clinical study of gamma/delta T cell therapy for non-small cell lung cancer
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 safety of adoptive transfer of autologous-gamma/delta T lymphocytes, as well as its efficacy, for patients with non-small cell lung cancer in a dose-escalating manner.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Antitumor effect (response rate, duration of response), improvement of tumor-related maker, immunological parameter, QOL score and Progression-free survival.

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 Gamma/delta T cells are to be administrated intravenously 6 times on a biweekly-basis.
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
-whose life-expectancy is 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;
-who have received continuous systemic steroids;
-who are pregnant, to be pregnant, or nursing mothers;
-whom principle investigator or co-investigator judged to be inappropriate to participate in this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Nakajima
Organization University of Tokyo, Graduate School of Medicine
Division name Department of Cardiothoracic surge
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kakimi
Organization University of Tokyo, Graduate School of Medicine
Division name Department of Immunotherapeutics
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5805-3161
Homepage URL
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute University of Tokyo, Graduate School of Medicine
Institute
Department

Funding Source
Organization Medinet Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Seta Clinic Shin-Yokohama
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology

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)

Other administrative information
Date of disclosure of the study information
2006 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Patient PBMC were stimulated with zoledronate (5 uM) and IL-2 (1000 IU/ml) for 14 days. Harvested cells, mostly gamma/delta T cells were given intravenously every 2 weeks without additional IL-2, a total of 6 times. The cumulative number of transferred gamma/delta T cells ranged from 2.6 to 45.1x10*9 (median 15.7x10*9). Fifteen patients underwent adoptive immunotherapy with these gamma/delta T cells. There were no severe adverse events related to the therapy. All patients remained alive during the study period with a median survival of 589 days and median progression-free survival of 126 days. According to the RECIST criteria, there were no objective responses. Six patients had SD whereas the remaining 6 evaluable patients experienced PD 4 weeks after the 6th transfer. We conclude that adoptive transfer of zoledronate-expanded gamma/delta T cells is safe and feasible in patients with NSCLC refractory to other treatments.
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
2006 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)Eur J Cardiothorac Surg 2010;37(5):1191-7.
2)J Immunother 2011;34(2):202-11.

Management information
Registered date
2006 Year 02 Month 22 Day
Last modified on
2013 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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