Clinical study on safety and efficacy of adoptive transfer of autologous gamma/delta T lymphocytes in patients with non-small cell lung cancer.

UMIN ID: C000000336

Registered date:01/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 2006/03/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Gamma/delta T cells are to be administrated intravenously 6 times on a biweekly-basis.

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Antitumor effect (response rate, duration of response), improvement of tumor-related maker, immunological parameter, QOL score and Progression-free survival.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who have: -uncontrolled infections; -active autoimmune diseases; -serious cardiac disease; -other cancers; -who have received continuous systemic steroids; -who are pregnant, to be pregnant, or nursing mothers; -whom principle investigator or co-investigator judged to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: University of Tokyo, Graduate School of Medicine
• Secondary Sponsor: Seta Clinic Shin-Yokohama
• Source(s) of Monetary Support: Medinet Co., Ltd.,Ministry of Education, Culture, Sports, Science and Technology