Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
Recruiting · NCT07486089 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Biotech
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Peking University Shenzhen Hospital - Shenzhen, Guangdong, China