T-Cell Gene Therapy to Eradicate Disseminated Breast Cancers
Abstract
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: 10^9, 10^10 and 10^11 T cells. During this report period, we treated our final patient on the 10^10 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- May 01, 2011
- Accession Number
- ADA548789
Entities
People
- Richard Junghans
Organizations
- Roger Williams Medical Center