NCT06347068RecruitingPhase 1
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 27 Jun 2024
- Primary completion date
- 22 May 2028
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06347068
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 42
- From 27 Jun 2024 to the primary completion date, 22 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
- Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.