Actively Recruiting
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-22
42
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC 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 at consent
- Karnofsky score greater than 60%
- Histologically confirmed triple-negative breast cancer (ER-, PR-, HER2-negative)
- ER- and PR-negative defined as less than 1% staining by immunohistochemistry
- HER2-negative defined as IHC 0-1+ or FISH ratio less than 2.0
You will not qualify if you...
- History of symptomatic central nervous system involvement or multiple metastases needing whole-brain radiation
- Prior or concurrent malignancy that could interfere with safety or efficacy assessment
- Lack of measurable or evaluable disease by RECIST 1.1 criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Caroline Babinec
CONTACT
C
Catherine Cheng
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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