Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer
UNC Lineberger Comprehensive Cancer Center
Summary
This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).
Description
T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) treatment is experimental and has not been approved by the Food and Drug Administration. The safety of iC9-CAR.B7-H3 T cells will be investigated using a modified 3+3 design. The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD) and additional factors such as the ability to manufacture sufficient cells for infusion. Subjects with TNBC who meet procurement eligibility criteria will have cells coll…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study: 1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. 2. Age ≥ 18 years at the time of consent. 3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale)) 4. Histologically confirmed TNBC (ER-, PR-, HER2-negative) 1. ER- and PR-negative: defined as \< 1% stainin…
Interventions
- BiologicaliC9-CAR.B7-H3 T Cell Therapy
iC9-CAR.B7-H3 T cells will then be administered intravenously
- Drugcyclophosphamide
cyclophosphamide 300 mg/m2 IV will be given.
- Drugfludarabine
fludarabine 30 mg/m2 IV will be given.
Location
- University of North CarolinaChapel Hill, North Carolina