Advanced Lung CancerPhase 1NCT06945523
Clinical Study on Chimeric Antigen Receptor T Lymphocyte (CAR-T) Targeting CEA for the Treatment of CEA - Positive Advanced Lung Cancer
A Phase 1 study testing Targeted CEA CAR-T in people with Advanced Lung Cancer, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- Targeted CEA CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 30 Apr 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
- Age ≥18 years, regardless of gender.
- Histologically or cytologically confirmed diagnosis of advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
- Disease progression or intolerance following at least one line of prior therapy (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy).
- For patients with pleural effusion enrolled in the intrapleural infusion group, accurate assessment of pleural effusion volume and characteristics must be conducted via imaging (chest CT or X-ray) combined with cytological analysis. Cytological examination must confirm the presence of tumor cells in the pleural effusion, indicating malignant pleural effusion.
- Positive tumor CEA expression confirmed by immunohistochemistry (IHC) within 3 months prior to screening (defined as clear membranous staining with a positivity rate ≥10%). If IHC testing of tumor samples was performed more than 3 months prior to screening, the patient's serum CEA must be >10 ng/mL.
- At least one measurable lesion according to RECIST 1.1 criteria: for non-nodal lesions, the longest diameter must be ≥10 mm; for nodal lesions, the short axis must be ≥15 mm.
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- ECOG performance status score of 0-2.
- Expected survival of more than 12 weeks.
- No severe psychiatric disorders.
- Unless otherwise specified, key organ functions must meet the following requirements:
- Hematologic: WBC >2.0×10⁹/L, neutrophils >1.0×10⁹/L, lymphocytes >0.5×10⁹/L, platelets >50×10⁹/L, hemoglobin >80 g/L;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography, and no significant abnormalities on ECG;
- Renal function: Serum creatinine ≤2.0×ULN;
- Hepatic function: ALT and AST ≤3.0×ULN (≤5.0×ULN if liver metastases are present);
- Total bilirubin ≤2.0×ULN;
- Oxygen saturation (SpO₂) >92% on room air.
- Eligible for leukapheresis or peripheral venous blood collection and without contraindications for cell collection.
- Subjects must agree to use reliable and effective contraception (excluding rhythm method) from the time of informed consent until 1 year after CAR-T cell infusion.
- Subject or legally authorized representative must voluntarily sign the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.
Who cannot join
- Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal metastases at screening, or other evidence indicating that CNS or leptomeningeal lesions are not adequately controlled, making the patient unsuitable for enrollment as judged by the investigator.
- Participation in another clinical study within 1 month prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Prior antitumor therapies before screening including: chemotherapy, targeted therapy, or other investigational drugs administered within 14 days or at least 5 half-lives (whichever is shorter) before screening.
- Active or uncontrolled infections requiring systemic treatment.
- Tumor compressing the trachea or major blood vessels with high risk as assessed by the investigator.
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- Presence of any of the following cardiac conditions:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;
- Clinically significant ventricular arrhythmias or a history of unexplained syncope (excluding vasovagal or dehydration-related causes);
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.
- History of other untreated or concurrent malignancies within the past 3 years, except for adequately treated cervical carcinoma in situ or basal cell carcinoma of the skin.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels exceeding the normal range in peripheral blood; positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels exceeding the normal range in peripheral blood; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.
- Pregnant or breastfeeding women.
- Any other condition that, in the opinion of the investigator, renders the patient 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
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430030
Shuang Wei, MD, +86 18062087116, wsdavid2001@163.com
Shuang Wei, MD
About this study
Official title: Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer
Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months.
CEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types.
In previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.
Read the detailed description
This study is a single-arm, open, enhanced 3+3 dose-ascending + dose-extending clinical study, aiming to evaluate the safety and efficacy of CAR T cell preparations, initially observe and study the pharmacokinetic characteristics of drugs in CEA positive advanced lung cancer patients, and obtain the recommended dose of CAR T cell preparations for CEA positive advanced lung cancer patients.
- Conditions
- Advanced Lung Cancer
- Being tested
- Targeted CEA CAR-T
- Keywords
- CEA, CAR-T, Advanced Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted CEA CAR-TBiological
Subjects meeting the transfusion criteria will receive pre-treatment, which is as follows: fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, and intravenous CEA CAR-T therapy after 1-2 days of rest
Targeted CEA CAR-TBiological
Subjects meeting the reinfusion criteria will receive pre-treatment with fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, rest for 1-2 days, and intraperitoneal reinfusion targeted CEA CAR-T therapy
| Study group | Role | What they receive |
|---|---|---|
| Targeted CEA CAR-T intravenous infusion group | Experimental | Not described Receives: Biological: Targeted CEA CAR-T |
| Targeting CEA CAR-T pleural infusion group | Experimental | Not described Receives: Biological: Targeted CEA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of CAR T cell preparations in the treatment of CEA positive advanced lung cancer【safety】
Adverse events and their proportion during the trial (assessed against the Common Terminology Standard for Adverse Events Version 5.0 (CTCAE 5.0) and ASTCT standards)
Measured: 28days
Secondary outcomes (8)
To evaluate the disease control rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy】
Disease control rates at 3 months were assessed according to Response Evaluation Criteria in Solid Tumors,Version 1.1 (RECIST 1.1), including CR, PR, and SD
Measured: 3months
To evaluate the remission rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy
Objective response rates at 3 months were assessed according to RECIST 1.1, including CR, PR
Measured: 3months
To evaluate the overall survival of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Overall survival (OS) : The time from the time the subject received CAR T cell retransfusion until death (from any cause)
Measured: 2years
To evaluate the duration of response of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Duration of response (DOR) : the time from the first evaluation of CR, PR, or SD to the first evaluation of disease recurrence or progression or death from any cause
Measured: 2years
To evaluate the disease progression-free survival of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Disease progression-free survival (PFS) : the time from the time the subject received CAR T cell therapy until the first disease progression or death from any cause
Measured: 2years
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacokinetics】
Cmax:The highest concentration of CAR T cells amplified in peripheral blood after reinfusion
Measured: 3months
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacokinetics】
Tmax:The time to reach the highest concentration of CAR-T cells in peripheral blood after reinfusion
Measured: 3months
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacodynamics】
The content of free CEA in peripheral blood at each time point after transfusion was determined by immunohistochemical method
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start28 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945523
- Sponsor's protocol ID
- PBC082
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 4 Jun 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT06945523
- Acronym / sponsor ID
- PBC082
- Conditions
- Advanced Lung Cancer
- Keywords
- CEA, CAR-T, Advanced Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 25 Apr 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.
Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and have a poor prognosis. The 5-year survival rate of stage III patients is about 15%, the 5-year survival rate of stage IV patients is less than 5%, and the median survival time is only 7 months.
CEACAM5 (CEA), also known as CD66e, is a classic tumor marker that has been used as a marker for many types of tumors for 50 years. It is mainly expressed in lung cancer, esophageal cancer, bile duct cancer, colorectal cancer, gastric cancer and other tumor types.
In previous CAR-T-related clinical trials targeting CEA, the research team found that CAR-T cell preparations had a certain killing effect on CEA positive tumor cells. At the same time, CAR-T cell preparations cannot be sustained for a long time in the body, which is also a key factor restricting the anti-tumor effect of CAR-T cells in the body. To solve this problem, the killing ability and survival ability of CAR-T cell preparations on tumor cells in vitro and in vivo were improved by optimizing CAR structure and improving culture mode.
Detailed description
This study is a single-arm, open, enhanced 3+3 dose-ascending + dose-extending clinical study, aiming to evaluate the safety and efficacy of CAR T cell preparations, initially observe and study the pharmacokinetic characteristics of drugs in CEA positive advanced lung cancer patients, and obtain the recommended dose of CAR T cell preparations for CEA positive advanced lung cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted CEA CAR-T intravenous infusion group | Experimental | Biological: Targeted CEA CAR-T |
| Targeting CEA CAR-T pleural infusion group | Experimental | Biological: Targeted CEA CAR-T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years, regardless of gender.
- Histologically or cytologically confirmed diagnosis of advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
- Disease progression or intolerance following at least one line of prior therapy (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy).
- For patients with pleural effusion enrolled in the intrapleural infusion group, accurate assessment of pleural effusion volume and characteristics must be conducted via imaging (chest CT or X-ray) combined with cytological analysis. Cytological examination must confirm the presence of tumor cells in the pleural effusion, indicating malignant pleural effusion.
- Positive tumor CEA expression confirmed by immunohistochemistry (IHC) within 3 months prior to screening (defined as clear membranous staining with a positivity rate ≥10%). If IHC testing of tumor samples was performed more than 3 months prior to screening, the patient's serum CEA must be >10 ng/mL.
Key exclusion criteria (16 listed)
- Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal metastases at screening, or other evidence indicating that CNS or leptomeningeal lesions are not adequately controlled, making the patient unsuitable for enrollment as judged by the investigator.
- Participation in another clinical study within 1 month prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Prior antitumor therapies before screening including: chemotherapy, targeted therapy, or other investigational drugs administered within 14 days or at least 5 half-lives (whichever is shorter) before screening.
- Active or uncontrolled infections 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 |
|---|---|---|
| Targeted CEA CAR-TSubjects meeting the transfusion criteria will receive pre-treatment, which is as follows: fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, and intravenous CEA CAR-T therapy after 1-2 days of rest | Biological | Targeted CEA CAR-T intravenous infusion group |
| Targeted CEA CAR-TSubjects meeting the reinfusion criteria will receive pre-treatment with fludarabine 25mg/m2/d×3day and cyclophosphamide 300mg/m2/d×3day, rest for 1-2 days, and intraperitoneal reinfusion targeted CEA CAR-T therapy | Biological | Targeting CEA CAR-T pleural infusion group |
Primary outcome
To evaluate the safety and tolerability of CAR T cell preparations in the treatment of CEA positive advanced lung cancer【safety】
Time frame: 28days
Adverse events and their proportion during the trial (assessed against the Common Terminology Standard for Adverse Events Version 5.0 (CTCAE 5.0) and ASTCT standards)
8 secondary outcomes
To evaluate the disease control rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy】
Time frame: 3months
To evaluate the remission rate of CAR-T cell preparations in CEA positive advanced lung cancer【efficacy
Time frame: 3months
To evaluate the overall survival of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Time frame: 2years
To evaluate the duration of response of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Time frame: 2years
To evaluate the disease progression-free survival of CAR-T cell preparations in CEA-positive advanced lung cancer【efficacy】
Time frame: 2years
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacokinetics】
Time frame: 3months
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacokinetics】
Time frame: 3months
To obtain the cytodynamics data of CAR-T cells in vivo【pharmacodynamics】
Time frame: 2years
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 4 Jun 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.
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 Targeted CEA CAR-T in people with Advanced Lung Cancer, run by Chongqing Precision Biotech Co., Ltd 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 4 Jun 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 Shuang Wei, MD (18062087116, wsdavid2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of CAR T cell preparations in the treatment of CEA positive advanced lung cancer【safety】 (time frame: 28days). 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 4 Jun 2025.