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

UMIN ID: UMIN000001835

Registered date:01/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable digestive cancer, lung cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
• Secondary Sponsor: Hyakumanben clinic
• Source(s) of Monetary Support: None,None