Clinical study on medical value of adoptive immunotherapy with chemotherapy for stage IV colorectal cancer (COMVI study).

628 Background: Adoptive immunotherapy of cancer is evolving with the development of novel technologies for generating a large number of activated killer cells such as αβ T cells, γδ T cells, and natural killer (NK) cells. We conducted a pilot study to evaluate the safety and feasibility of the combination treatment of adoptive immunotherapy with chemotherapy for stage IV colorectal cancer. Methods: The COMVI study was a prospective and single-arm pilot trial. Therapy in each 21-day treatment cycle consisted of XELOX (130 mg/m2 of oxaliplatin on day 1 plus 1,000 mg/m2 of capecitabine twice daily on days 1–14), bevacizumab (7.5 mg/kg on day 1) and αβ T lymphocytes (over 5 ×109 on day 18) cultured ex vivo with an immobilized anti-CD3 antibody and interleukin-2. Results: A total of 6 patients were enrolled from June 2013 to September 2014. Baseline characteristics included a median age of 66 years (range: 55-75) for 2 men and 4women. Median PFS was 567 days. Overall response rate was 100 % (CR 33.3%, PR 66.7...