Unique ID issued by UMIN | UMIN000001835 |
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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 |
Phase1 study of adoptive cell transfer therapy for advanced cancer patients, using stimulated T cells by CH-296.
Adoptive CH-296-stimulated T cells transfer therapy
Phase1 study of adoptive cell transfer therapy for advanced cancer patients, using stimulated T cells by CH-296.
Adoptive CH-296-stimulated T cells transfer therapy
Japan |
unresectable digestive cancer, lung cancer
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Pneumology |
Malignancy
NO
To evaluate adverse events following adoptive CH-296-stimulated T cell transfer for advanced digestive cancer and lung cancer
Safety
Exploratory
Pragmatic
Phase I
Adverse events
response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
9
1st name | |
Middle name | |
Last name | Toshikazu Yoshikawa |
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Molecular Gastroenterology and Hepatology
Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075-251-5519
s-kokura@koto.kpu-m.ac.jp
1st name | |
Middle name | |
Last name | Satoshi Kokura |
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Molecular Gastroenterology and Hepatology
Kawaramachi-Hirokoji, Kaigyo-ku, Kyoto, Japan
075(251)5519
s-kokura@koto.kpu-m.ac.jp
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
None
Self funding
Japan
Hyakumanben clinic
None
NO
2009 | Year | 04 | Month | 01 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/24497917
Completed
2009 | Year | 02 | Month | 24 | Day |
2009 | Year | 04 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2009 | Year | 04 | Month | 01 | Day |
2015 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002101
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