Colorectal CancerPhase 1NCT05415475
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors
A Phase 1 study testing CEA CAR-T cells in people with Colorectal Cancer and Esophageal Cancer, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Stomach Cancer
- What is being tested?
- CEA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to 15 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 old, male or female;
- Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
- After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
- Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); the patient's serum CEA should exceed 10ug/L.
- At least one assessable lesion according to RECIST 1.1 criteria;
- ECOG score 0-2 points;
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- No serious mental disorder;
- Unless otherwise specified, the function of the vital organs of the subject shall meet the following conditions:
- Blood routine: white blood cells>2.0×109/L, neutrophils>0.8×109/L, lymphocytes cells>0.5×109/L, platelets>50×109/L, hemoglobin>90g/L;
- Cardiac function: echocardiography showed cardiac ejection fraction ≥50%, and no obvious abnormality was found on electrocardiogram;
- Renal function: serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤3.0×ULN (for those with liver tumor infiltration, it can be relaxed to≤5.0×ULN);
- Total bilirubin≤2.0×ULN;
- Oxygen saturation > 92% in non-oxygen state.
- Have apheresis or venous blood collection standards, and have no other contraindications for cell collection;
- Subjects agree to use reliable and effective contraceptive methods for contraception within 1 year after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception);
- The patients themselves or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
Who cannot join
- Previous CAR-T therapy or other gene-modified cell therapy；
- CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;
- Participated in other clinical studies within 1 month before screening;
- vaccinated with live attenuated vaccine within 4 weeks before screening;
- Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
- Active infection or uncontrollable infection requiring systemic treatment;
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- Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
- Except for alopecia or peripheral neuropathy, the toxicity of previous anti-tumor therapy has not improved to the baseline level or ≤ grade 1;
- Suffering from any of the following heart diseases:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia, or history of syncope of unknown origin (caused by vasovagal except those caused by neurosis or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Patients with active autoimmune disease, or other patients requiring long-term immunosuppressive therapy;
- Suffering from other uncured malignant tumors in the past 3 years or at the same time, except cervical carcinoma in situ and basal cell carcinoma of the skin;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer is greater than the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Virus (HCV) RNA test is greater than the normal range; human immunodeficiency virus (HIV) antibody positive; syphilis test positive;
- Women who are pregnant or breastfeeding;
- Other investigators deem it unsuitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors
This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.
Read the detailed description
Carcinoembryonic antigen (CEA) is a classic tumor marker, which is positively expressed in a variety of digestive tract tumors. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of digestive tract cells. In the early clinical trials of CAR-T targeting CEA carried out by the technical partner, it was found that CAR-T cell preparations have a certain killing effect on CEA-positive tumor cells. At the same time, no serious CAR-T-related adverse events were found through dose-escalating infusion. In this study, through the optimization of the CAR structure and the improvement of the culture method, the killing ability and survival ability of the CAR-T cell preparation on tumor cells in vitro and in vivo were improved to further verify the safety and efficacy.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Stomach Cancer, Pancreatic Cancer, Metastatic Tumor, Recurrent Cancer
- Being tested
- CEA CAR-T cells
- Keywords
- CAR-T, CEA, CEA-positive advanced malignant solid tumors
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA CAR-T cellsBiological
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with 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 1-10x107 copy/kg Receives: Biological: CEA CAR-T cells |
| intraperitoneal injection of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 1-10x107 copy/kg Receives: Biological: CEA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Measured: 28 days
Secondary outcomes (6)
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Disease control rate: including CR, PR and SD
Measured: 3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Changes in serum tumor markers：CEA、 CA199、 CA125
Measured: 3 months
AUCS of CEA-CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 28 days and 90 days
Measured: 1 years
CMAX of CEA-CAR-T cells [Cell dynamics]
CMAX is defined as the highest concentration of CEA-CAR-T cells expanded in peripheral blood
Measured: 1 years
TMAX of CEA-CAR-T cells[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 1 years
Pharmacodynamics of CEA-CAR-T cells[Cell dynamics]
The content of free CEA in peripheral blood at each time point measured by Chemiluminescence immunoassay
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start10 Sep 2021
- Primary completion15 Jun 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingwang Bi, M.D, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415475
- Sponsor's protocol ID
- PBC034
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05415475
- Acronym / sponsor ID
- PBC034
- Conditions
- Colorectal Cancer, Esophageal Cancer, Stomach Cancer, Pancreatic Cancer, Metastatic Tumor, Recurrent Cancer
- Keywords
- CAR-T, CEA, CEA-positive advanced malignant solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 13 Jun 2022 (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 trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.
Detailed description
Carcinoembryonic antigen (CEA) is a classic tumor marker, which is positively expressed in a variety of digestive tract tumors. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of digestive tract cells. In the early clinical trials of CAR-T targeting CEA carried out by the technical partner, it was found that CAR-T cell preparations have a certain killing effect on CEA-positive tumor cells. At the same time, no serious CAR-T-related adverse events were found through dose-escalating infusion. In this study, through the optimization of the CAR structure and the improvement of the culture method, the killing ability and survival ability of the CAR-T cell preparation on tumor cells in vitro and in vivo were improved to further verify the safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 1-10x107 copy/kg |
| intraperitoneal injection of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 1-10x107 copy/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years old, male or female;
- Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer;
- After receiving at least second-line standard treatment and failing (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment methods;
- Immunohistochemical staining of tumor samples within 3 months confirmed that the tumor was CEA positive (clear membrane staining, positive rate ≥ 10%); the patient's serum CEA should exceed 10ug/L.
- At least one assessable lesion according to RECIST 1.1 criteria;
Key exclusion criteria (18 listed)
- Previous CAR-T therapy or other gene-modified cell therapy；
- CNS metastases or meningeal metastases with clinical symptoms at the time of screening, or there is other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for inclusion;
- Participated in other clinical studies within 1 month before screening;
- vaccinated with live attenuated vaccine within 4 weeks before screening;
- Received the following anti-tumor treatments before screening: Received chemotherapy, targeted therapy or other experimental drug treatments 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 |
|---|---|---|
| CEA CAR-T cellsAdministration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | Intravenous of CEA-targeted CAR-T, intraperitoneal injection of CEA-targeted CAR-T |
Primary outcome
Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]
Time frame: 28 days
Dose-limiting toxicity after cell infusion
6 secondary outcomes
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Time frame: 3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
Time frame: 3 months
AUCS of CEA-CAR-T cells [Cell dynamics]
Time frame: 1 years
CMAX of CEA-CAR-T cells [Cell dynamics]
Time frame: 1 years
TMAX of CEA-CAR-T cells[Cell dynamics]
Time frame: 1 years
Pharmacodynamics of CEA-CAR-T cells[Cell dynamics]
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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. This study is not recruiting at the moment.
Jingwang Bi, M.D principal investigator
Shandong Provincial Hospital
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 CAR-T cells in people with Colorectal Cancer and Esophageal 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 17 inclusion and 18 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: finished, as of the sponsor's last update on 9 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days). 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 9 Jul 2026.