Natural immune cells engineered to fight advanced breast cancer

Plain-English translation of NCT07486089 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This study is testing a new treatment called dual-target CAR-NK cells — natural immune cells from a donor that have been engineered in the laboratory to better recognize and attack breast cancer cells. The treatment uses your body's own immune system to fight cancer that has spread or cannot be removed by surgery. Researchers will first test different doses to find the safest amount, then study how well it works in patients with specific types of advanced breast cancer.

Many people with advanced HER2-positive or triple-negative breast cancer run out of effective treatment options because their cancer becomes resistant to standard drugs. This medication offers a new approach by using engineered immune cells to attack cancer cells in a different way, potentially helping patients who have already tried other treatments.

Do you qualify?

You likely qualify if…

you have been diagnosed with locally advanced, unresectable, or metastatic breast cancer that is either HER2-positive or triple-negative
your cancer has progressed despite previous treatment, or you cannot tolerate or are ineligible for standard therapies
you have at least one measurable tumor that can be evaluated by imaging
your tumor samples show expression of at least one of the target proteins the treatment is designed to attack
you are in good enough general health to participate (ECOG performance status 0–1) and have adequate blood counts, heart function, and organ function

You likely don't qualify if…

you have untreated brain or spinal cord metastases (though treated, stable metastases may be allowed)
you have received another type of engineered cell therapy (such as CAR-T or CAR-NK) within the past 6 months
you have an active autoimmune disease that requires ongoing immunosuppressive medications
you have an uncontrolled infection, including untreated HIV, hepatitis B, or hepatitis C
you are pregnant, breastfeeding, or unable to use effective birth control during and for 6 months after treatment

What participation looks like

If you qualify and enroll, you will first undergo chemotherapy to prepare your body (fludarabine and cyclophosphamide). Then you will receive a single infusion of the engineered immune cells intravenously. The trial is divided into two phases: an initial phase that tests increasing doses to find the safest amount, followed by an expansion phase that studies effectiveness in larger groups of patients with specific cancer types. You will have regular follow-up visits to monitor for side effects and check whether your cancer is responding to treatment.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(1 site)

China

Peking University Shenzhen Hospital, Shenzhen, Guangdong