UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001835
Receipt number R000002101
Scientific Title Phase1 study of adoptive cell transfer therapy for advanced cancer patients, using stimulated T cells by CH-296.
Date of disclosure of the study information 2009/04/01
Last modified on 2015/10/11 13:07:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase1 study of adoptive cell transfer therapy for advanced cancer patients, using stimulated T cells by CH-296.

Acronym

Adoptive CH-296-stimulated T cells transfer therapy

Scientific Title

Phase1 study of adoptive cell transfer therapy for advanced cancer patients, using stimulated T cells by CH-296.

Scientific Title:Acronym

Adoptive CH-296-stimulated T cells transfer therapy

Region

Japan


Condition

Condition

unresectable digestive cancer, lung cancer

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate adverse events following adoptive CH-296-stimulated T cell transfer for advanced digestive cancer and lung cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Adverse events

Key secondary outcomes

response rate


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 T cells.
Dose-escalation study with three groups
1x10*9 cells 3 patients
3x10*9 cells 3 patients
9x10*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 digestive cancer or lung cancer.
2) Patients informed diagnosis of their disease
3) Patients must have recurrent disease after standard treatment, and in the situation where curative treatment opions are not available.
4) Patients must have residual disease after standard treatment, and in the situation where curative treatment options are not available.
5) Without planning to recieve chemotherapy, radiation therapy or BRM. Oral 5-FU drugs are permitted.
6) Aged from 20 to 80 years
7) Grade 0 to 2 in performance status(ECOG).
8) Expected to be alive at least three months after informed consent.
9) Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous administration of 5-FU. But oral 5-FU drugs are permitted.
10) Sufficient functions of major organ.
11) 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) Active other malignancy, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable.
6) Medical history of severe hypersensitivity.
7) Severe mental impairment
8) Pregnant or lactating women
9) Inappropriate patients for study judged by the physicians.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshikazu Yoshikawa

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code


Address

Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

075-251-5519

Email

s-kokura@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Kokura

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code


Address

Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan

TEL

075(251)5519

Homepage URL


Email

s-kokura@koto.kpu-m.ac.jp


Sponsor or person

Institute

Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Hyakumanben clinic

Name of secondary funder(s)

None


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

2009 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/24497917

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

2009 Year 02 Month 24 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2009 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 04 Month 01 Day

Last modified on

2015 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002101


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name