Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- iC9-CAR.B7-H3 T Cell Therapy
- cyclophosphamide
- fludarabine
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
M.D. Anderson Cancer Center
Collaborator
Source ClinicalTrials.gov