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Phase Ib Trial of 2nd Generation Designer T Cells in Metastatic Breast Cancer

Richard Junghans, MD, PhD, Associate Professor of Medicine, Boston University School of Medicine, and Roger Williams Medical Center, Providence, Rhode Island
Study abstract

Hypotheses: that designer T cells offer an immune based alternative to cancer therapies that has the potential to cure metastatic breast cancers; that several components will potentially contribute to an optimal therapeutic anti-tumor agent; that CEA, which is the 2nd most prevalent tumor antigen on breast cancers, is the optimal platform for a rapid optimization that will allow generalizable lessons over the range of breast cancer antigens.

Specific Aims:
Clinical (existing products):
1. To test efficacy of 2nd gen designer T cells in metastatic breast cancer
2. To test ancillary procedures for improved persistence and activity of infused designer T cells
Advanced Research & Development:
3. To create and test other CIR designs with alternative co-stimulatory domains
4. To create and test CIR with to avoid need for IL2 supplementation in vivo to sustain T cell survival
Clinical (new products):
5. To conduct clinical trials with the new generation products.

Study review

This study at Boston University School of Medicine and Roger Williams Medical Center is investigating whether a high dose of designer T cells is better when given with or without interleukin 2 (IL2), a drug that is thought to stimulate the immune system. Study participants were randomly assigned to either receive modified T cells alone or modified T cells along with IL2. The researchers wanted to enroll up to 11 volunteers in the Providence area and they enlisted the Army of Women (AOW) to help support their recruitment efforts. The Call to Action for this study was sent to AOW members on July 13, 2011, and the researchers closed enrollment on March 31, 2015. The AOW provided them with 47 women who were interested in enrolling in the study.