Non-Small Cell Lung CancerPhase 1NCT06972576
Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer
A Phase 1 study testing EphA2-targeted CAR-T Cells and EphA2-targeted CAR-DCs in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- EphA2-targeted CAR-T Cells and EphA2-targeted CAR-DCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2025to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Ying Yuan, +86-13858193601, yuanying1999@zju.edu.cn
About this study
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.
Read the 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 maximum tolerated dose of EphA2-targeted CAR-DCs when administered in combination with CAR-T cells.
Secondary purpose:
To assess the overall response rate (ORR), including complete response (CR) and partial response (PR), as well as overall survival (OS) and disease-free survival (DFS) in patients receiving the combination therapy.
To evaluate the in vivo persistence, immunophenotype, and functional activity of CAR-T cells and CAR-DCs following infusion.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- EphA2-targeted CAR-T Cells, EphA2-targeted CAR-DCs
- Keywords
- Chimeric Antigen Receptor Dendritic Cells, Chimeric Antigen Receptor T-Cells, Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphA2-targeted CAR-T CellsBiological
Autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2
EphA2-targeted CAR-DCsBiological
Autologous dendritic cells (DCs) genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2
| Study group | Role | What they receive |
|---|---|---|
| CAR-T and CAR-DC Combination Therapy | Experimental | This arm involves the sequential administration of two biological interventions with EphA2-targeted CAR-DCs administered first, followed by EphA2-targeted CAR-T cells. Receives: Biological: EphA2-targeted CAR-T Cells; Biological: EphA2-targeted CAR-DCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate adverse events occurring within the first three months following infusion of EphA2-targeted CAR- T cells and CAR-DCs. The assessment includes incidence and severity of treatment-related symptoms such as neurological toxicity, hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Measured: First 3 month post CAR-T cells and CAR-DCs infusion
Efficacy: Remission Rate
To evaluate the proportion of participants who achieve an objective tumor response, including complete remission (CR) and partial remission (PR)
Measured: 3 months post CAR-T cells and CAR-DCs infusion
Secondary outcomes (7)
Progression-Free Survival
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
Overall Survival
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
Relapse Rate
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
Duration of Response
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
In Vivo Persistence of CAR-T cells and CAR-DCs and Cytokine Profile Monitoring
The copy number of CAR-T cells and CAR-DCs in PBMCs will be measured by qPCR to assess in vivo persistence.
Serum cytokine levels, including IL-2, IL-4, IL-6, IFN-γ, TNF-α, IL-10, IL-12, and IL-17A, will be quantified by ELISA to evaluate immune activation following cell infusion.
Measured: First 2 weeks post CAR-T cells and CAR-DCs infusion
Objective Response Rate in Participants Receiving Different Doses of CAR-DCs
The proportion of participants in each CAR-DCs dose cohort (5x10^6, 1x10^7, 3x10^7, and 9x10^7 cells) who achieve an objective tumor response, including completeremission (CR) or partial remission (PR). All participants received a fixed dose of EphA2-targeted CAR-T cells (2x10^6 cells/kg) following CAR-DCs infusion.
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
Incidence and Severity of Treatment-Related Adverse Events in Participants Receiving Different Doses of CAR-DCs
To evaluate adverse events occurring following infusion of EphA2-targeted CAR-DCs and CAR-T cells. Participants will receive CAR-DCs at one of four dose levels (5x10^6, 1x1 0^7, 3x10^7, and 9x10^7 cells), followed by a fixed dose of EphA2-targeted CAR-T cells(2x10^6 cells/kg). The assessment includes the incidence and severity of treatment-related symptoms such as neurological toxicity, hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Measured: Up to 24 months post CAR-T cells and CAR-DCs infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start9 May 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Yuan, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972576
- Sponsor's protocol ID
- 2022-0164
- Status last verified
- Apr 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06972576
- Acronym / sponsor ID
- 2022-0164
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Chimeric Antigen Receptor Dendritic Cells, Chimeric Antigen Receptor T-Cells, Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 May 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 maximum tolerated dose of EphA2-targeted CAR-DCs when administered in combination with CAR-T cells.
Secondary purpose:
To assess the overall response rate (ORR), including complete response (CR) and partial response (PR), as well as overall survival (OS) and disease-free survival (DFS) in patients receiving the combination therapy.
To evaluate the in vivo persistence, immunophenotype, and functional activity of CAR-T cells and CAR-DCs following infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T and CAR-DC Combination Therapy | Experimental | Biological: EphA2-targeted CAR-T Cells, Biological: EphA2-targeted CAR-DCsThis arm involves the sequential administration of two biological interventions with EphA2-targeted CAR-DCs administered first, followed by EphA2-targeted CAR-T cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- Clinically significant bleeding tendency or coagulation disorders, such as hemophilia.
- HIV or syphilis infection; active hepatitis B or C:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EphA2-targeted CAR-T CellsAutologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2 | Biological | CAR-T and CAR-DC Combination Therapy |
| EphA2-targeted CAR-DCsAutologous dendritic cells (DCs) genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2 | Biological | CAR-T and CAR-DC Combination Therapy |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First 3 month post CAR-T cells and CAR-DCs infusion
To evaluate adverse events occurring within the first three months following infusion of EphA2-targeted CAR- T cells and CAR-DCs. The assessment includes incidence and severity of treatment-related symptoms such as neurological toxicity, hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Efficacy: Remission Rate
Time frame: 3 months post CAR-T cells and CAR-DCs infusion
To evaluate the proportion of participants who achieve an objective tumor response, including complete remission (CR) and partial remission (PR)
7 secondary outcomes
Progression-Free Survival
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
Overall Survival
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
Relapse Rate
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
Duration of Response
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
In Vivo Persistence of CAR-T cells and CAR-DCs and Cytokine Profile Monitoring
Time frame: First 2 weeks post CAR-T cells and CAR-DCs infusion
Objective Response Rate in Participants Receiving Different Doses of CAR-DCs
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
Incidence and Severity of Treatment-Related Adverse Events in Participants Receiving Different Doses of CAR-DCs
Time frame: Up to 24 months post CAR-T cells and CAR-DCs infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Yuan principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EphA2-targeted CAR-T Cells and EphA2-targeted CAR-DCs in people with Non-Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Yuan (+86-13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First 3 month post CAR-T cells and CAR-DCs infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.