Study Details

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Triple Negative Breast Cancer (TNBC) T Cell Study

This research study is a gene therapy study. In this study, the treatment uses your own blood cells after they are modified (changed) to attack and destroy cancer cells. This research study will test doses of modified blood cells. The study will look at whether each dose is safe, tolerable, and effective in destroying cancer cells. The study will also look at harms and side effects of administering modified blood cells to people with your type of cancer. This treatment is experimental and has not been approved by the Food and Drug Administration (FDA) for treating triple negative breast cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

After a consultation with the study team, you will undergo a series of tests to determine if it is safe for you to proceed with participation. If so, your blood cells (lymphocytes) will be collected and the manufacturing process started. During that process, your cells will be altered with the intent of making those cells more effective in killing your breast cancer cells. If your CAR-T cells are successfully made, you will again undergo several tests to make sure it is safe for you to proceed with participation in the treatment portion of the study. If you remain eligible, you'll complete three days of chemotherapy that will prepare our body to better accept the modified cells. 2-3 days after completion of that chemotherapy regimen, you will receive the iC9.CAR.B7-H3 T cells. Both the chemotherapy and CAR-T infusions will occur in an outpatient setting (ie you will not be required to be admitted to the hospital). You will have to stay near the hospital after infusion and will be seen frequently in clinic for follow up assessments that may include lab tests, imaging, or biopsies of your tumor. You will continue follow up visits based on how well you have responded to the study treatment.

In-person visits:
Variable - based on disease and side effects

Phone or online visits:
Variable - based on worsened disease

Total length of participation:
Up to 15 years - this includes treatment, short-term follow up, and long-term follow up.

Looking for Specific Volunteers

Able to participate:

You have confirmed triple negative breast cancer, that has returned following most recent treatment.
You are willing and able to comply with study procedures and requirements.
You are willing to undergo a biopsy at various timepoints throughout the study.
You are able to care for most of your personal needs on your own.

Not eligible if:

You have another cancer, besides breast cancer, for which you currently require ongoing treatment.
You have an active infection with HIV, Hep B, or Hep C virus.
You require the use of systemic corticosteroids like dexamethasone or prednisone (exceptions for patients taking low daily doses).
Your organ function is inadequate, per study guidelines.
5.) You have spread of your disease to your brain which requires treatment (and has not yet been treated).

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Immunotherapy Team
UNCImmunotherapy@med.unc.edu

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Claire Dees
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

23-3242

ClinicalTrials.gov

NCT06347068