RecruitingPhase 1NCT06347068

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

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

42 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Relapse Resistant Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria3

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