Actively Recruiting
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
Led by Beijing Biotech · Updated on 2026-04-06
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
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,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
CONDITIONS
Official Title
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced, unresectable, or metastatic breast carcinoma
- Breast cancer subtype must be HER2-positive or triple-negative
- Disease progressed after or is intolerant/ineligible for standard therapies for the subtype
- At least one measurable lesion per RECIST v1.1 criteria
- Available tumor antigen assessment (HER2/ERBB2, MUC1, or ROR1) on fresh or archival tissue
- ECOG performance status of 0 or 1
- Adequate organ function with specific blood count and chemistry thresholds
- Left ventricular ejection fraction (LVEF) of 45% or higher with no uncontrolled arrhythmia
- Negative pregnancy test if of childbearing potential and agreement to contraception use during and 6 months post treatment
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Active, untreated central nervous system metastases or leptomeningeal disease; treated CNS metastases eligible if stable for 4 weeks and off high-dose steroids
- Prior gene-modified cellular therapy within 6 months or unresolved grade 2 or higher toxicity from prior cell therapy
- Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement allowed)
- Uncontrolled infections including HBV, HCV, or HIV (controlled infections may be eligible)
- History of severe hypersensitivity to fludarabine or cyclophosphamide
- Pregnant or breastfeeding
- Participation in another interventional study that may affect safety or efficacy assessments
- Any condition making the participant unsuitable per investigator judgment, including uncontrolled comorbidities or inability to comply with protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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