Engineered immune cells take on Hard-to-Treat breast cancer

NCT ID NCT06347068

Recruiting now Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new type of immune cell therapy called CAR-T cells that target a protein called B7-H3 on triple-negative breast cancer cells. The cells also have a safety switch to stop them if needed. Up to 42 adults whose cancer has returned or not responded to treatment will receive these cells along with two chemotherapy drugs. The main goal is to find a safe dose and understand side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: iC9-CAR.B7-H3 T cells (a type of immune cell therapy) given with chemotherapy drugs cyclophosphamide and fludarabine
What this could lead to: If it works, this could point toward a new treatment option for people with triple-negative breast cancer that has come back or not responded to other therapies.
What could go wrong: This is a very early phase 1 trial with only 42 people, so it is mainly checking safety, not effectiveness. The treatment can cause serious side effects like cytokine release syndrome and nerve problems.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Recurrence refractory malignant neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER RELAPSE RESISTANT CANCER TRIPLE NEGATIVE BREAST CANCER

Contacts and locations

Locations

University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27599, United States

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