UMIN-CTR Clinical Trial

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

Non small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

University of Tokyo, Graduate School of Medicine

Institute

Department

Personal name

Organization

Medinet Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Seta Clinic Shin-Yokohama

Name of secondary funder(s)

Ministry of Education, Culture, Sports, Science and Technology

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院（東京都）

Date of disclosure of the study information

2006

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

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

Registered date

2006

Year

02

Month

22

Day

Last modified on

2013

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000431