Status:
RECRUITING
Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Main purpose: To evaluate the safety of EphA2-targeted CAR-T cells in combination with CAR-DCs in patients with advanced non-small cell lung cancer during the dose-escalation phase. To determine the...
Eligibility Criteria
Inclusion
- Pathologically confirmed stage IV non-small cell lung cancer (NSCLC) with at least one measurable lesion according to RECIST 1.1 criteria (i.e., a lesion with the longest diameter ≥10 mm on spiral CT scan or a lymph node with a short axis ≥15 mm).
- Tumor tissue tested positive for EphA2 expression by immunohistochemistry (≥20%).
- Disease progression after standard treatment or no available standard treatment (patients must have received at least two prior systemic therapies, including but not limited to chemotherapy and immune checkpoint inhibitors; patients with actionable driver mutations must have failed targeted therapy).
- ECOG performance status: 0-1.
- Expected survival ≥6 months.
- Toxicities related to prior anti-tumor treatments must have resolved to baseline levels or ≤ Grade 1 (excluding residual alopecia); Grade ≤2 neurotoxicity is acceptable. Washout periods: 4 weeks for chemotherapy and immunotherapy, 2 weeks for targeted therapy.
- Adequate organ function, including:
- Adequate hematologic function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥75×10\^9/L, hemoglobin ≥9 g/dL. No transfusions, granulocyte colony-stimulating factor (G-CSF), thrombopoietin, or erythropoietin allowed within 14 days before blood tests.
- Adequate hepatic function: Total bilirubin (TBIL) \<1.5× upper limit of normal (ULN); AST and ALT \<2.5×ULN. For patients with Gilbert's syndrome, TBIL \<2×ULN; if liver metastases are present, AST and ALT \<5×ULN.
- Adequate renal function: Serum creatinine (Cr) ≤1.5×ULN, or if Cr \>1.5×ULN, creatinine clearance (CrCl) ≥60 mL/min calculated using the Cockcroft-Gault formula.
- Adequate coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) \<1.5×ULN; international normalized ratio (INR) \<1.5 or within the target range if on anticoagulant therapy.
- Subjects of reproductive potential must be willing to use effective contraception.
- Ability to understand and voluntarily sign the informed consent form.
- Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion
- Pathologically confirmed mixed histology, such as adenosquamous carcinoma of the lung.
- Tumor-related emergencies requiring urgent treatment, such as malignant pericardial effusion or cardiac tamponade, superior vena cava syndrome, or spinal cord compression.
- Significant cardiovascular diseases, including:
- Documented cardiovascular events within the past 6 months, such as myocardial infarction, angina, heart failure, severe arrhythmia, or having undergone angioplasty, stent implantation, or coronary artery bypass surgery.
- Clinically significant QT/QTcF prolongation (QT/QTcF \> 470 ms in females or \> 450 ms in males).
- Clinically significant bleeding tendency or coagulation disorders, such as hemophilia.
- HIV or syphilis infection; active hepatitis B or C:
- Hepatitis B: HBV-DNA ≥ 1000 IU/mL.
- Hepatitis C: Positive HCV RNA with abnormal liver function.
- History of involuntary commitment due to psychiatric disorders or other psychological conditions deemed unsuitable for treatment by the investigator.
- Presence of other autoimmune diseases, or long-term use of immunosuppressive agents or corticosteroids.
- Poor medication compliance.
- Any other condition that the investigator considers grounds for exclusion.
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06972576
Start Date
May 9 2025
End Date
April 1 2027
Last Update
May 15 2025
Active Locations (1)
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1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009