Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
Recruiting · NCT06347068 · Interventional (participants receive a specific treatment) · Lead sponsor: UNC Lineberger Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:
- 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.
- Age ≥ 18 years at the time of consent.
- Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
- Histologically confirmed TNBC (ER-, PR-, HER2-negative)
- ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
- HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
Exclusion criteria
- Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
- Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
Where it is running
1 location listed across 1 US state.
- University of North Carolina - Chapel Hill, North Carolina, United States