No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for people with relapsed or resistant triple-negative breast cancer. Participants will receive increasing doses of a special type of immune cell therapy called CAR-T cells.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with triple-negative breast cancer.
I have given my consent and understand the study.
My health status is good enough to participate.
You may not be able to join if
I have had symptoms related to brain cancer.
I have had another cancer that might affect the study.
I do not have measurable disease as defined in the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:
1. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained …
Inclusion Criteria:
Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study:
1. 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.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)
1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
Exclusion Criteria:
1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
2. 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.
3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
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