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

Recruiting now · Phase 1/Phase 2

Conditions studied: Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)

In brief

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.

Key facts

Study ID

NCT07486089

Run by

Beijing Biotech

People needed

60

Starts

2026-02-02

Expected to finish

2028-03-17

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.
• Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).
• Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.
• At least one measurable lesion per RECIST v1.1.
• Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1). For TNBC, mesothelin assessment may be performed for exploratory analyses.
• ECOG performance status 0-1.
• Adequate organ function (example thresholds): ANC ≥ 1.0 x 10\^9/L; platelets ≥ 75 x 10\^9/L; hemoglobin
• 8 g/dL; AST/ALT ≤ 3x ULN (≤ 5x with liver metastases); total bilirubin ≤ 1.5x ULN; creatinine clearance
• 50 mL/min.
• Left ventricular ejection fraction (LVEF) ≥ 45% and no uncontrolled cardiac arrhythmia.
• Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception during study treatment and for 6 months after last CAR-NK infusion.
• Ability to understand and willingness to sign informed consent.

You may not qualify if…

• Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.
• Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.
• Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
• Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).
• History of severe hypersensitivity to fludarabine or cyclophosphamide.
• Pregnant or breastfeeding.
• Concurrent participation in another interventional study that could confound safety or efficacy assessments.
• Any condition that, in the investigator's judgment, would make the participant unsuitable for the study (e.g., uncontrolled comorbidity, inability to comply with protocol procedures).

Where it is running

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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