T-Cell Gene Therapy to Eradicate Disseminated Breast Cancers

摘要

This Aim applies a randomization of 12 subjects to IL2 or +IL2 arms at the maximum tolerated dose (MTD) or maximum practical dose (MPD) of designer T cells under a Phase Ib design. This will test the optimal biologic dose (OBD) in terms of the benefit of IL2 to T cell persistence and activity in vivo. There were three dose levels in the original Phase Ia: 10(careT)9, 10(caret)10 and 10(caret)11 T cells. During this report period, we treated our final patient on the 10(caret)10 dose (level 2), completing the first two cohorts. In the first two cohorts, all patients had good tolerance of the designer T cells. One patient had a minor response to treatment, with shrinkage of brain and lung mets, but with resurgence of disease in subsequent months. This is a situation in which we postulated that addition of IL2 will allow a more prolonged and deeper response. A second patient had stable disease without other effective treatment for 12+ months.