NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1PBC102NCT07250386
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
A Phase 1 study testing CEA-targeted CAR-T (Intravenous) and CEA-targeted CAR-T (Intrapleural) in people with NSCLC (Advanced Non-small Cell Lung Cancer) and Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), Breast Cancer
- What is being tested?
- CEA-targeted CAR-T (Intravenous) and CEA-targeted CAR-T (Intrapleural)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2025to 30 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, of any gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
- Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate ≥10%). If the IHC result is more than 3 months old, serum CEA must be above 10 ng/mL.
- At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm for lymph node lesions. Malignant pleural effusion is acceptable for the chest infusion subgroup.
- For patients with malignant pleural effusion, accurate volume assessment of pleural effusion by imaging (CT or MRI) and cytological or thoracoscopic biopsy confirmation of malignant pleural effusion.
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- ECOG performance status of 0-2.
- Life expectancy of 12 weeks or more.
- No serious psychiatric disorders.
- The following organ function criteria should be met unless otherwise specified:
- Hematology: White blood cell count >2.0×10^9/L, neutrophils >1.0×10^9/L, lymphocytes >0.5×10^9/L, platelets >50×10^9/L, hemoglobin >80 g/L.
- Cardiac function: Echocardiography showing ejection fraction ≥50%, with no significant abnormalities on ECG.
- Renal function: Serum creatinine ≤2.0×ULN.
- Liver function: ALT and AST ≤3.0×ULN (≤5.0×ULN for those with liver tumor infiltration).
- Total bilirubin ≤2.0×ULN.
- Oxygen saturation >92% without supplemental oxygen.
- Eligible for single or venous blood collection with no contraindications to cell collection.
- Consent to use a reliable and effective method of contraception for 1 year after CAR-T cell infusion (excluding the rhythm method).
- The participant or their authorized guardian agrees to participate in the clinical trial and signs the informed consent form (ICF), indicating an understanding of the trial's purpose and procedures.
Who cannot join
- Clinical symptoms of CNS metastasis or meningeal metastasis at screening, or other evidence suggesting that CNS metastasis or meningeal metastasis is uncontrolled, as determined by the investigator.
- Participation in other clinical trials within 4 weeks prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of chemotherapy, targeted therapy, or other experimental drugs within 14 days or at least 5 half-lives (whichever is shorter) prior to screening.
- Active or uncontrolled infection requiring systemic treatment.
- Tumor compression of the trachea or major blood vessels, with significant risk as assessed by the investigator.
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- History of any of the following cardiac diseases:
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening.
- Clinically significant ventricular arrhythmias or unexplained syncope (except those caused by vasovagal or dehydration).
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune disease or other conditions requiring long-term immunosuppressive therapy.
- History of or concurrent untreated malignancies within 3 years, except for basal cell carcinoma or in situ cervical cancer.
- Positive for HBsAg or HBcAb with HBV DNA levels above the normal range, HCV antibody positive with HCV RNA levels above the normal range, HIV antibody positive, or positive for syphilis.
- Pregnant or breastfeeding women.
- Any other condition that the investigator deems unsuitable for participation in the study.
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
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310017
Fuming Qiu, PhD, +86 13858005908, qiufuming@zju.edu.cn
Fuming Qiu, PhD
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Read the detailed description
According to the different infusion methods, patients will be assigned to two parallel subgroups: intravenous infusion, intrapleural infusion.
Within each subgroup, the study is conducted in two sequential parts:
- .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;
- .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.
- Being tested
- CEA-targeted CAR-T (Intravenous), CEA-targeted CAR-T (Intrapleural)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA-targeted CAR-T (Intravenous)Biological
Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion
CEA-targeted CAR-T (Intrapleural)Biological
Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 2-6x10^5 cells/kg Receives: Biological: CEA-targeted CAR-T (Intravenous) |
| Intrapleural infusion of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 2-6x10^5 cells/kg Receives: Biological: CEA-targeted CAR-T (Intrapleural) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Measured: From infusion through Month 3
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies [Safety and Tolerability]
Dose-limiting toxicity after CEA CAR-T cell infusion
Measured: From infusion through Month 3
Secondary outcomes (9)
Assessing disease control(DCR) rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
DCR: The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: From infusion through Month 3
Objective response rate (ORR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Objective response rate includes：The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 2 years
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death(Assessed based on RECIST criteria)
Measured: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
PFS will be assessed from the first CEA-CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)
Measured: 2 years
Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
OS will be assessed from the first CEA-CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)
Measured: 2 years
To evaluate the efficacy of CAR-T cell preparations in CEA-positive advanced malignancies【Effectiveness】
Changes in serum tumor marker levels: CEA, CA-125, etc.
Measured: 2 years
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Cmax: maximum observed level of circulating CAR-T cells in peripheral blood after infusion
Measured: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
To determine the time to maximum observed level of circulating CAR-T cells (Tmax)
Measured: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR [T cells#pharmacokinetics]
To estimate AUC0-28d and AUC0-90d for circulating CAR-T cells
Measured: From infusion through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start13 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two experimental cohorts by infusion route - intravenous (IV) and intrathoracic (IT). Each cohort conducts sequential dose escalation using an enhanced 3+3 design (3 dose levels; 3-6 participants per level depending on DLTs), followed by optional dose expansion at 1-2 selected dose levels. The two route cohorts may run in parallel operationally, but enrollment within each cohort proceeds sequentially per the dose-escalation scheme.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Fuming Qiu, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicineJunqiang Fan, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250386
- Sponsor's protocol ID
- 2025-0883
- Acronym
- PBC102
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07250386
- Acronym / sponsor ID
- PBC102 / 2025-0883
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Nov 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 study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
Detailed description
According to the different infusion methods, patients will be assigned to two parallel subgroups: intravenous infusion, intrapleural infusion.
Within each subgroup, the study is conducted in two sequential parts:
- .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;
- .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two experimental cohorts by infusion route - intravenous (IV) and intrathoracic (IT). Each cohort conducts sequential dose escalation using an enhanced 3+3 design (3 dose levels; 3-6 participants per level depending on DLTs), followed by optional dose expansion at 1-2 selected dose levels. The two route cohorts may run in parallel operationally, but enrollment within each cohort proceeds sequentially per the dose-escalation scheme.
| Arm | Type | Receives |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | Experimental | Biological: CEA-targeted CAR-T (Intravenous)Infusion of CEA-targeted CAR-T cells by dose of 2-6x10^5 cells/kg |
| Intrapleural infusion of CEA-targeted CAR-T | Experimental | Biological: CEA-targeted CAR-T (Intrapleural)Infusion of CEA-targeted CAR-T cells by dose of 2-6x10^5 cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Aged 18 years or older, of any gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
- Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate ≥10%). If the IHC result is more than 3 months old, serum CEA must be above 10 ng/mL.
- At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm for lymph node lesions. Malignant pleural effusion is acceptable for the chest infusion subgroup.
Key exclusion criteria (16 listed)
- Clinical symptoms of CNS metastasis or meningeal metastasis at screening, or other evidence suggesting that CNS metastasis or meningeal metastasis is uncontrolled, as determined by the investigator.
- Participation in other clinical trials within 4 weeks prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of chemotherapy, targeted therapy, or other experimental drugs within 14 days or at least 5 half-lives (whichever is shorter) prior to screening.
- Active or uncontrolled infection requiring systemic treatment.
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 |
|---|---|---|
| CEA-targeted CAR-T (Intravenous)Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion | Biological | Intravenous of CEA-targeted CAR-T |
| CEA-targeted CAR-T (Intrapleural)Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion | Biological | Intrapleural infusion of CEA-targeted CAR-T |
Primary outcome
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
Time frame: From infusion through Month 3
Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies [Safety and Tolerability]
Time frame: From infusion through Month 3
Dose-limiting toxicity after CEA CAR-T cell infusion
9 secondary outcomes
Assessing disease control(DCR) rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Time frame: From infusion through Month 3
Objective response rate (ORR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Time frame: 2 years
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Time frame: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Time frame: 2 years
Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]
Time frame: 2 years
To evaluate the efficacy of CAR-T cell preparations in CEA-positive advanced malignancies【Effectiveness】
Time frame: 2 years
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Time frame: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
Time frame: From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR [T cells#pharmacokinetics]
Time frame: From infusion through Month 3
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 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Fuming Qiu, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Junqiang Fan, PhD 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 CEA-targeted CAR-T (Intravenous) and CEA-targeted CAR-T (Intrapleural) in people with NSCLC (Advanced Non-small Cell Lung Cancer) and Breast 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 19 inclusion and 16 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 26 Nov 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 Fuming Qiu, PhD (+86 13858005908, qiufuming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability] (time frame: From infusion through Month 3). 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 26 Nov 2025.