Actively Recruiting
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-14
27
Participants Needed
1
Research Sites
609 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization
- Age 18 years or older
- ECOG performance status of 0 to 2
- Histologically or cytologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer with high-grade serous histology
- Recurrent platinum-resistant or platinum-refractory disease defined by progression during platinum treatment or recurrence within 6 months after last platinum chemotherapy
- At least two prior treatment regimens including front-line therapy
You will not qualify if you...
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Unable or unwilling to comply with study procedures
- Unwilling to undergo biopsies before treatment, after infusion, and at disease progression if tumor biopsy is deemed safe by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine Cheng
CONTACT
C
Caroline Babinec
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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