Solid TumorPhase 1/2NCT04348643
Safety and Efficacy of CEA-Targeted CAR-T Therapy for Relapsed/Refractory CEA+ Cancer
A Phase 1/2 study testing CEA CAR-T cells in people with Solid Tumor and Lung Cancer, run by Chongqing Precision Biotech Co., Ltd at 2 sites in China.
Trial summary
This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Lung Cancer, Colorectal 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
- 0 participants
- Where
- 2 sitesChina
- Study dates
- 20 Feb 2020to 30 Apr 2024
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No gender limitation, age 18-75 years old (including boundary value);
- Late, metastatic, or recurrent malignant tumors that have received at least first-line standard treatment failure (progressive or intolerable disease, such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, and the tumor CEA positive expression (tumor CEA positive or serum CEA level> 50ng / ml confirmed by histology or pathology);
- There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
- The expected survival time is more than 12 weeks;
- KPS≥60 ;
- No serious mental disorders;
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- The functions of important organs are basically normal:
- Blood routine: white blood cells> 2.0 × 10^9 / L, neutrophils> 0.8 × 10^9 / L, lymphocytes> 0.5 × 10^9 / L, platelets> 50 × 10^9 / L, hemoglobin> 90g / L;
- Cardiac function: cardiac ultrasound indicates that the cardiac ejection fraction is ≥50%, and there is no obvious abnormality on the electrocardiogram;
- Renal function: serum creatinine and urea nitrogen ≤3.0 × ULN;
- Liver function: ALT and AST ≤5.0 × ULN; total bilirubin ≤3.0 × ULN;
- Blood oxygen saturation> 92%.
- There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation);
- There are no contraindications for apheresis or intravenous blood collection or other cell collection;
- The patient or his guardian agrees to participate in this clinical trial and sign the ICF, indicating that he understands the purpose and procedures of this clinical trial and is willing to participate in the study.
Who cannot join
- Have received CAR-T treatment or other genetically modified cell treatment before screening;
- Participated in other clinical studies within 1 month before screening;
- Received the following anti-tumor treatment before screening: received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except for those who have confirmed disease progression after treatment;
- Have received live attenuated vaccine within 4 weeks before screening;
- Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
- Suffering from any of the following heart diseases:
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- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction occurred or received coronary artery bypass graft (CABG) ≤6 months before enrollment;
- Clinically significant ventricular arrhythmias, or history of syncope of unknown cause (except for conditions caused by vasovagal or dehydration);
- Severe cardiac insufficiency, severe heart valve disease and other cardiovascular system diseases;
- There are active infections or uncontrollable infections requiring systemic treatment within 2 weeks before screening;
- Active autoimmune diseases;
- Suffering from chronic enteritis and / or intestinal obstruction;
- Suffering from other malignant tumors, in addition to fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection 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;
- The situation that other researchers think is not suitable for participating in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Henan Cancer Hospital
Henan
About this study
Official title: Clinical Study of CEA-Targeted CAR-T Therapy in Patients With Relapsed and Refractory CEA+ Cancer
This is a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
Read the detailed description
CEA is a classic tumor marker, especially in more than 80% of colorectal cancer patients. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of the digestive tract cells, and the CEA is expressed toward the cell cavity under physiological conditions to avoid recognition by CAR-T cells targeting CEA. This is a study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy,and obtain the recommended dose and infusion plan.
- Conditions
- Solid Tumor, Lung Cancer, Colorectal Cancer, Liver Cancer, Pancreatic Cancer, Gastric Cancer
- Being tested
- CEA CAR-T cells
- Keywords
- CAR-T, Solid Tumor, Lung Cancer, Colorectal Cancer, Liver Cancer, Pancreatic Cancer, Gastric Cancer, Breast Cancer
- Medical subject headings
- Lung Neoplasms, Colorectal Neoplasms, Liver Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA CAR-T cellsBiological
CEA-CAR-T cells will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| CEA+ CAR-T | Experimental | CAR-T cell reinfusion is carried out in 1~3 times Receives: Biological: CEA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 2 years
Secondary outcomes (9)
The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy
The response rate of CEA CAR-T treatment will be recorded and assessed according to the irRECIST Version 1.1
Measured: 6 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause
Measured: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression
Measured: 2 years
Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
OS will be assessed from the first CAR-T cell infusion to death from any cause
Measured: 2 years
Levels of CEA in Serum
In vivo (Serum) quantity of CEA
Measured: 2 years
Rate of CEA CAR-T cells in peripheral blood
In vivo (peripheral blood) rate of CEA CAR-T cells were determined by means of flow cytometry
Measured: 2 years
Quantity of CEA CAR copies in peripheral blood
In vivo (peripheral blood) quantity of CEA CAR copies were determined by means of qPCR
Measured: 2 years
Levels of IL-6 in Serum
In vivo (Serum) quantity of IL-6
Measured: 3 months
Levels of CRP in Serum
In vivo (Serum) quantity of CRP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Feb 2020 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Why it stopped: The sponsor requested to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT04348643
- Sponsor's protocol ID
- PBC017
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CEA-Targeted CAR-T Therapy in Patients With Relapsed and Refractory CEA+ Cancer
- ClinicalTrials.gov ID
- NCT04348643
- Acronym / sponsor ID
- PBC017
- Conditions
- Solid Tumor, Lung Cancer, Colorectal Cancer, Liver Cancer, Pancreatic Cancer, Gastric Cancer
- Keywords
- CAR-T, Solid Tumor, Lung Cancer, Colorectal Cancer, Liver Cancer, Pancreatic Cancer, Gastric Cancer, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor requested to terminate the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 16 Apr 2020 (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 a single arm study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy for patients with relapsed/refractory CEA+ Cancer,and obtain the recommended dose and infusion plan.
Detailed description
CEA is a classic tumor marker, especially in more than 80% of colorectal cancer patients. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of the digestive tract cells, and the CEA is expressed toward the cell cavity under physiological conditions to avoid recognition by CAR-T cells targeting CEA. This is a study to evaluate the efficacy and safety of CEA-targeted CAR-T cells therapy,and obtain the recommended dose and infusion plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEA+ CAR-T | Experimental | Biological: CEA CAR-T cellsCAR-T cell reinfusion is carried out in 1~3 times |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- No gender limitation, age 18-75 years old (including boundary value);
- Late, metastatic, or recurrent malignant tumors that have received at least first-line standard treatment failure (progressive or intolerable disease, such as surgery, chemotherapy, radiotherapy, targeted therapy, etc.) or lack effective treatment, and the tumor CEA positive expression (tumor CEA positive or serum CEA level> 50ng / ml confirmed by histology or pathology);
- There are measurable and assessable lesions: the diameter of the lesion under CT or MRI scan is greater than 0.5cm;
- The expected survival time is more than 12 weeks;
- KPS≥60 ;
Key exclusion criteria (17 listed)
- Have received CAR-T treatment or other genetically modified cell treatment before screening;
- Participated in other clinical studies within 1 month before screening;
- Received the following anti-tumor treatment before screening: received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except for those who have confirmed disease progression after treatment;
- Have received live attenuated vaccine within 4 weeks before screening;
- Cerebrovascular accident or seizure occurred within 6 months before signing the ICF;
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 cellsCEA-CAR-T cells will be administered intravenously. | Biological | CEA+ CAR-T |
Primary outcome
Adverse events that related to treatment
Time frame: 2 years
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
9 secondary outcomes
The response rate of CEA CAR-T treatment in patients with relapse/refractory CEA+ Cancer that treatment by CEA CAR-T cells therapy
Time frame: 6 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time frame: 2 years
Progress-free survival(PFS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time frame: 2 years
Overall survival(OS) of CEA CAR-T treatment in patients with refractory/relapsed CEA+ Cancer
Time frame: 2 years
Levels of CEA in Serum
Time frame: 2 years
Rate of CEA CAR-T cells in peripheral blood
Time frame: 2 years
Quantity of CEA CAR copies in peripheral blood
Time frame: 2 years
Levels of IL-6 in Serum
Time frame: 3 months
Levels of CRP in Serum
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CEA CAR-T cells in people with Solid Tumor and Lung Cancer, run by Chongqing Precision Biotech Co., Ltd at 2 sites 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 15 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: withdrawn, as of the sponsor's last update on 10 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 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse events that related to treatment (time frame: 2 years). 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 10 Jul 2026.