RecruitingPhase 1Phase 2NCT07486089

Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)

Phase 1/2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2/ERBB2, MUC1, and/or ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).


Sponsor

Beijing Biotech

Enrollment

60 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1, and in some TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called dual-target CAR-NK cell therapy in adults with advanced HER2-positive or triple-negative breast cancer (TNBC), two forms of breast cancer that are difficult to treat. The therapy uses engineered natural killer (NK) cells from a donor, customized to target two proteins on the surface of the patient's tumor simultaneously. You may be eligible if you are an adult with advanced or metastatic breast cancer that has progressed despite standard treatments, have measurable disease, an ECOG performance status of 0 or 1, and adequate organ function; tumor tissue will be tested to confirm the right CAR-NK product for your tumor profile. Participation involves receiving a short course of lymphodepleting chemotherapy followed by an infusion of the CAR-NK cells, with close monitoring for safety and response. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALDual-target CAR-NK cells (EB-DT-CAR-NK)

Route: IV infusion. Schedule: single infusion on Day 0; optional second infusion on Day 7 in the absence of dose-limiting toxicity (DLT) and with adequate clinical status.

DRUGLymphodepleting chemotherapy

fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4), prior to CAR-NK infusion.

OTHERSupportive care

Premedication per institutional standard (e.g., acetaminophen and antihistamine). Tumor lysis and infection prophylaxis per institutional guidelines.


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07486089


Related Trials