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Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.
Official title: Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) and Containing the Inducible Caspase 9 Safety Switch in Subjects With Recurrent Platinum Resistant Epithelial Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2024-07-29
Completion Date
2026-03
Last Updated
2025-09-15
Healthy Volunteers
No
Interventions
iC9-CAR.B7-H3 T cells
iC9-CAR.B7-H3 T cells will then be administered intraperitoneally
Cyclophosphamide
cyclophosphamide 300 mg/m2 IV will be given.
Fludarabine
fludarabine 30 mg/m2 IV will be given.
Locations (1)
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States