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Recruiting Phase 1 / Phase 2

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

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About this study

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.

Condition
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
Tested
Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
Sponsor
Beijing Biotech

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
  • 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.

Exclusion 8

  • 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

1 site, 1 recruiting

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.