Actively Recruiting
Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-05-15
18
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of EphA2-targeted CAR-DC combined with CAR-T cell therapy in patients with non-small cell lung cancer.
CONDITIONS
Official Title
Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed stage IV non-small cell lung cancer with at least one measurable lesion per RECIST 1.1 criteria
- Tumor tissue positive for EphA2 expression (≥20%) by immunohistochemistry
- Disease progression after standard treatment or no available standard treatment; must have had at least two prior systemic therapies including chemotherapy and immune checkpoint inhibitors; failed targeted therapy if applicable
- ECOG performance status 0-1
- Expected survival of at least 6 months
- Toxicities from prior anti-tumor treatments resolved to baseline or ≤ Grade 1 (except alopecia); Grade ≤2 neurotoxicity acceptable; washout periods of 4 weeks for chemotherapy/immunotherapy and 2 weeks for targeted therapy
- Adequate organ function: hematologic, hepatic, renal, and coagulation parameters within specified limits
- Willingness to use effective contraception if of reproductive potential
- Ability to understand and voluntarily sign informed consent
- Willingness to comply with study visits, treatment plans, and procedures
You will not qualify if you...
- Mixed histology lung cancer such as adenosquamous carcinoma
- Tumor-related emergencies requiring urgent treatment (e.g., malignant pericardial effusion, cardiac tamponade, superior vena cava syndrome, spinal cord compression)
- Significant cardiovascular disease within the past 6 months including myocardial infarction, angina, heart failure, severe arrhythmia, or recent cardiac interventions
- Clinically significant QT/QTcF prolongation (>470 ms females, >450 ms males)
- Bleeding tendencies or coagulation disorders such as hemophilia
- HIV or syphilis infection; active hepatitis B or C with specified viral load or abnormal liver function
- History of psychiatric disorders requiring involuntary commitment or unsuitable psychological condition
- Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids
- Poor medication compliance
- Any other condition deemed exclusionary by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Ying Yuan
CONTACT
S
Shanshan Weng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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