Advanced Lung CancerPhase 1NCT06992583
Targeted Anti-CEA CAR-T Immunotherapy for 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
- 8 May 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
- -
- Participants must meet all of the following criteria to be eligible for enrollment:
- Age ≥18 years, regardless of gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
- Disease progression or intolerance after receiving standard therapies (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy):
- NSCLC: Disease progression or intolerance after at least second-line standard therapy.
Show all 22Show fewer
- SCLC: Disease progression or intolerance after at least first-line standard therapy.
- For patients with pleural effusion assigned to the intrapleural infusion group, the pleural effusion volume and characteristics must be accurately assessed by imaging (chest CT or X-ray) combined with cytology. Malignant pleural effusion must be confirmed by the presence of tumor cells in pleural fluid cytology.
- Tumor CEA positivity confirmed by immunohistochemistry (IHC) within 3 months prior to screening, defined as distinct membranous staining with ≥10% positivity. If the tumor sample was assessed more than 3 months prior to screening, a serum CEA level >10 µg/L is required.
- At least one measurable lesion according to RECIST 1.1 criteria:
- Non-nodal lesions: longest diameter ≥10 mm. Lymph node lesions: short axis ≥15 mm.
- ECOG performance status score of 0 to 2 .
- Estimated life expectancy of more than 12 weeks.
- No severe psychiatric disorders.
- Adequate major organ function unless otherwise specified, defined as follows:
- Hematology: 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: LVEF ≥ 50% on echocardiogram; no significant abnormalities on ECG.
- Renal function: Serum creatinine ≤ 2.0 × ULN. Hepatic function: ALT and AST ≤ 3.0 × ULN (≤ 5.0 × ULN if there is hepatic tumor infiltration).
- Total bilirubin ≤ 2.0 × ULN. Peripheral oxygen saturation >92% in room air.
- Eligible for leukapheresis or venous blood collection, with no contraindications to cell collection.
- Willing to use reliable and effective contraception methods (excluding rhythm method) from informed consent signing until one year after CAR-T cell infusion.
- Participant or legally authorized representative has voluntarily signed the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.
Who cannot join
- -
- Participants who meet any of the following criteria will be excluded from the study:
- Clinically symptomatic central nervous system (CNS) metastasis or meningeal metastasis at screening, or other evidence suggesting the presence of uncontrolled CNS or meningeal metastasis, as judged by the investigator.
- Participation in any other clinical trial within 1 month prior to screening.
- Vaccination with a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of the following anti-tumor treatments within 4 weeks prior to screening: chemotherapy, targeted therapy, or any experimental drug treatment within 14 days or at least 5 half-lives (whichever is shorter).
Show all 17Show fewer
- Active infection requiring systemic treatment or any uncontrolled infection.
- Tumor compression of the trachea or major blood vessels, as determined by the investigator to carry a high risk.
- History of the following cardiac conditions:
- NYHA Class III or IV congestive heart failure. Myocardial infarction or coronary artery bypass graft (CABG) surgery within 6 months prior to enrollment.
- Clinically significant ventricular arrhythmias or a history of unexplained syncope (except due to vasovagal or dehydration-related causes).
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune disease or any condition requiring long-term immunosuppressive therapy.
- History of any other untreated malignancy within the past 3 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above normal range; positive for hepatitis C antibody with peripheral blood HCV RNA levels above normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.
- Pregnancy 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
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
Tangfeng Lv, MD, +86 13952016932, bairoushui@163.com
Tangfeng Lv, 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.
Note: The study was initiated on May 8, 2025, with the first participant providing written informed consent on the same date. Due to administrative delays, the registration on ClinicalTrials.gov was completed on May 16, 2025. No study outcomes were accessed, analyzed, or reported prior to the registration. All study procedures strictly adhere to the protocol approved by the ethics committee.
- 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: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start8 May 2025
- Primary completion29 Feb 2028 (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
- NCT06992583
- Sponsor's protocol ID
- PBC089
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 28 May 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 28 May 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
- NCT06992583
- Acronym / sponsor ID
- PBC089
- 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
- 8 May 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 28 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.
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.
Note: The study was initiated on May 8, 2025, with the first participant providing written informed consent on the same date. Due to administrative delays, the registration on ClinicalTrials.gov was completed on May 16, 2025. No study outcomes were accessed, analyzed, or reported prior to the registration. All study procedures strictly adhere to the protocol approved by the ethics committee.
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 (22 listed)
- -
- Age ≥18 years, regardless of gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
- Disease progression or intolerance after receiving standard therapies (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy):
- NSCLC: Disease progression or intolerance after at least second-line standard therapy.
Key exclusion criteria (17 listed)
- -
- Clinically symptomatic central nervous system (CNS) metastasis or meningeal metastasis at screening, or other evidence suggesting the presence of uncontrolled CNS or meningeal metastasis, as judged by the investigator.
- Participation in any other clinical trial within 1 month prior to screening.
- Vaccination with a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of the following anti-tumor treatments within 4 weeks prior to screening: chemotherapy, targeted therapy, or any experimental drug treatment within 14 days or at least 5 half-lives (whichever is shorter).
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: 2 years
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 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
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 22 inclusion and 17 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 28 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 Tangfeng Lv, MD (+86 13952016932, bairoushui@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 28 May 2025.