UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013378
Receipt number R000015605
Scientific Title The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer
Date of disclosure of the study information 2014/06/30
Last modified on 2018/09/10 18:08:27

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Basic information

Public title

The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer

Acronym

The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer

Scientific Title

The phase I clinical study about the combined therapy, high purity natural killer (NK) cell therapy and IgG1 antibody to inoperable advance and recurrence digestive cancer

Scientific Title:Acronym

The phase I clinical study about the combined therapy, natural killer (NK) cell therapy and IgG1 antibody to digestive cancer

Region

Japan


Condition

Condition

inoperable advance and recurrence stomach and colon cancer combined with IgG1 antibody in chemotherapy

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The safety about the repeated dose of cultivated NK cell to digestive cancer patient who had failed standard treatment was checked in the our previous phase I clinical study, so in this study, main purpose is to evaluate the safety of the combined therapy of the cultivated NK cell, chemotherapy and IgG1 antibody.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the kind, grade and frequency of adverse event about combined therapy with the cultivated NK cell and IgG1 antibody.

Key secondary outcomes



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

Interventions/Control_1

Intravenous transfer of autologous NK cells.
Dose-escalation study with three groups
1)5x10*8 cells 3 patients
2)1x10*9 cells 3 patients
3)2x10*9 cells 3 patients

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed gastric or colon cancer.
2) Patients informed diagnosis of their disease
3) In gastric cancer, patient must be cared with Capecitabine + Cisplatin + Trastuzumab or S-1 + Cisplatin + Trastuzumab chemotherapy regimen. In colon cancer, patient must be cared with Capecitabine + Oxaliplatin + Cetuximab or S-1 + Oxaliplatin + Cetuximab chemotherapy regimen.
4) Aged from 20 to 80 years
5) Grade 0 to 2 in performance status (ECOG).
6) Lasting at least four weeks since previous cell infusion therapy.
7) Sufficient functions of major organ.
8) Expected to be alive at least four months after informed consent.
9) Having written informed consent.

Key exclusion criteria

1) Presence of uncontrolled infection
2) Hypersensitivity or autoimmune disease requiring treatments
3) Presence of severe comlications(malignant hypertension, congestive heart failure, severe coronary disease, history of myocardial infarction less than six months prior, pulmonary fibrosis or active interstitial pneumonitis)
4) Inappropriate patients for this study due to severe complications.
5) Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction.
6) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable.
7) Medical history of severe hypersensitivity.
8) Severe mental impairment
9) Pregnant or lactating women
10) Patient with HBV, HCV, HIV, HTLV-1 or syphilis infection
11) Inappropriate patients for study judged by the physicians.
12) Patient with bad NK cell cultivation.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Cancer ImmunoCell Regulation

Zip code


Address

465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

iskw-t@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Ishikawa

Organization

Kyoto Prefectural University of Medicine

Division name

Cancer ImmunoCell Regulation

Zip code


Address

465, Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

iskw-t@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

TAKARA BIO, INC

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



Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29388200

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

2014 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 09 Day

Last modified on

2018 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015605


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name