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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001835
Receipt No. 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

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

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
URL(English) https://upload.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


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