Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

Recruiting now · Phase 1

Conditions studied: Breast Cancer, Relapse, Resistant Cancer, Triple Negative Breast Cancer

In brief

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).

Key facts

Study ID

NCT06347068

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

42

Starts

2024-06-27

Expected to finish

2030-05-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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