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

Phase 1

• Conditions: on small cell lung cancer

• Registration Number: JPRN-C000000336
• Lead Sponsor: niversity of Tokyo, Graduate School of Medicine

Brief Summary

Patient PBMC were stimulated with zoledronate (5 uM) and IL-2 (1000 IU/ml) for 14 days. Harvested cells, mostly gamma/delta T cells were given intravenously every 2 weeks without additional IL-2, a total of 6 times. The cumulative number of transferred gamma/delta T cells ranged from 2.6 to 45.1x10*9 (median 15.7x10*9). Fifteen patients underwent adoptive immunotherapy with these gamma/delta T cells. There were no severe adverse events related to the therapy. All patients remained alive during the study period with a median survival of 589 days and median progression-free survival of 126 days. According to the RECIST criteria, there were no objective responses. Six patients had SD whereas the remaining 6 evaluable patients experienced PD 4 weeks after the 6th transfer. We conclude that adoptive transfer of zoledronate-expanded gamma/delta T cells is safe and feasible in patients with NSCLC refractory to other treatments.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-01
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Antitumor effect (response rate, duration of response), improvement of tumor-related maker, immunological parameter, QOL score and Progression-free survival.