Colorectal CancerPhase 1NCT05396300
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
A Phase 1 study testing Intraperitoneal infusion of FAST CEA-targeted CAR-T and CEA CAR-T cells in people with Colorectal Cancer and Solid Cancers, run by Weijia Fang, MD at 1 site in China.
Trial summary
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Solid Cancers, Gastric Cancer
- What is being tested?
- Intraperitoneal infusion of FAST CEA-targeted CAR-T and CEA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 30 Jun 2026
- 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;
- 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%); If over 3 months, 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
- 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;
- Patients with intestinal obstruction, active gastrointestinal bleeding, or a history of gastrointestinal bleeding within 3 months;
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- 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.
China1 site
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Official title: A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Read the detailed description
This is a single-center, open-label, dose-escalation study consisting of three distinct treatment cohorts for patients with CEA-positive advanced malignant solid tumors:
Cohort 1 (Intravenous infusion): A dose-escalating (3+3 design) study with 4 dose levels,: 1.0×106, 3.0×106, 5.0×106 CAR+ cells/kg and 7.0×106 CAR+ cells/kg.
Cohort 2 (Intraperitoneal injection): A dose-escalating (3+3 design) study with 3 dose levels：1.0×106, 3.0×106,and 5.0×106 CAR+ cells/kg.
Cohort 3 (FAST CAR-T Intraperitoneal infusion): A dose-escalating study (3+3 design) with 4 dose levels: 2.0×10⁵, 3.0×10⁵, 4.0×10⁵, and 5.0×10⁵ CAR+ cells/kg.
- Conditions
- Colorectal Cancer, Solid Cancers, Gastric Cancer
- Being tested
- Intraperitoneal infusion of FAST CEA-targeted CAR-T, CEA CAR-T cells
- Keywords
- CAR-T, CEA, CEA-positive advanced malignant solid tumors
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal infusion of FAST CEA-targeted CAR-TBiological
Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.
CEA CAR-T cellsBiological
Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
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 |
|---|---|---|
| Intraperitoneal infusion of FAST CEA-targeted CAR-T | Experimental | Intraperitoneal infusion of FAST CEA-targeted CAR-T cells by 4 dose levels Receives: Biological: Intraperitoneal infusion of FAST CEA-targeted CAR-T |
| Intravenous of CEA-targeted CAR-T | Experimental | Infusion of CEA-targeted CAR-T cells by dose of 3-10x106 cells/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 3-10x106 cells/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 posted31 May 2022
- Study start25 May 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weijia Fang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Responsible party
- Sponsor-investigator, Weijia Fang, MD, Zhejiang University
- Investigators
- Weijia Fang, M.D, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396300
- Sponsor's protocol ID
- PBC039
- Status last verified
- Jul 2026
- First submitted
- 25 May 2022
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao Y, Li J, Zhang H, Zhang Y, Qian S, Zhu X, Hong L, Xie L, Fu Q, Bao X, Tong Z, Li Y, Li B, Wang L, Shen J, Zhang Q, He X, Zheng Y, Yao C, Liu L, Zhao P, Campos PV, Yang Z, Qian C, Fang W. Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial. Nat Cancer. 2026 Apr;7(4):608-621. doi: 10.1038/s43018-026-01124-3. Epub 2026 Feb 27.
PubMed 41760800Ye K, Yu C, Shen Z. Severe refractory colitis after intraperitoneal infusion of CEA-directed CAR T cells in patients with colorectal cancer. Ther Adv Med Oncol. 2024 Dec 23;16:17588359241309825. doi: 10.1177/17588359241309825. eCollection 2024.
PubMed 39734708
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05396300
- Acronym / sponsor ID
- PBC039
- Conditions
- Colorectal Cancer, Solid Cancers, Gastric Cancer
- Keywords
- CAR-T, CEA, CEA-positive advanced malignant solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Weijia Fang, MDUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 31 May 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 is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.
Detailed description
This is a single-center, open-label, dose-escalation study consisting of three distinct treatment cohorts for patients with CEA-positive advanced malignant solid tumors:
Cohort 1 (Intravenous infusion): A dose-escalating (3+3 design) study with 4 dose levels,: 1.0×106, 3.0×106, 5.0×106 CAR+ cells/kg and 7.0×106 CAR+ cells/kg.
Cohort 2 (Intraperitoneal injection): A dose-escalating (3+3 design) study with 3 dose levels：1.0×106, 3.0×106,and 5.0×106 CAR+ cells/kg.
Cohort 3 (FAST CAR-T Intraperitoneal infusion): A dose-escalating study (3+3 design) with 4 dose levels: 2.0×10⁵, 3.0×10⁵, 4.0×10⁵, and 5.0×10⁵ CAR+ cells/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal infusion of FAST CEA-targeted CAR-T | Experimental | Biological: Intraperitoneal infusion of FAST CEA-targeted CAR-TIntraperitoneal infusion of FAST CEA-targeted CAR-T cells by 4 dose levels |
| Intravenous of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 3-10x106 cells/kg |
| intraperitoneal injection of CEA-targeted CAR-T | Experimental | Biological: CEA CAR-T cellsInfusion of CEA-targeted CAR-T cells by dose of 3-10x106 cells/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;
- 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%); If over 3 months, the patient's serum CEA should exceed 10ug/L.
- At least one assessable lesion according to RECIST 1.1 criteria;
Key exclusion criteria (17 listed)
- 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;
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 |
|---|---|---|
| Intraperitoneal infusion of FAST CEA-targeted CAR-TIntraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion. | Biological | Intraperitoneal infusion of FAST CEA-targeted CAR-T |
| 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 |
| CEA CAR-T cellsAdministration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | 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 15 Jul 2026.
- Derived from this study: PubMed 41760800Gao Y, Li J, Zhang H, Zhang Y, Qian S, Zhu X, Hong L, Xie L, Fu Q, Bao X, Tong Z, Li Y, Li B, Wang L, Shen J, Zhang Q, He X, Zheng Y, Yao C, Liu L, Zhao P, Campos PV, Yang Z, Qian C, Fang W. Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial. Nat Cancer. 2026 Apr;7(4):608-621. doi: 10.1038/s43018-026-01124-3. Epub 2026 Feb 27.
- Derived from this study: PubMed 39734708Ye K, Yu C, Shen Z. Severe refractory colitis after intraperitoneal infusion of CEA-directed CAR T cells in patients with colorectal cancer. Ther Adv Med Oncol. 2024 Dec 23;16:17588359241309825. doi: 10.1177/17588359241309825. eCollection 2024.
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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.
Weijia Fang, M.D principal investigator
First Affiliated Hospital of Zhejiang University
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 Intraperitoneal infusion of FAST CEA-targeted CAR-T and CEA CAR-T cells in people with Colorectal Cancer and Solid Cancers, run by Weijia Fang, MD 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 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: finished, as of the sponsor's last update on 15 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?
On the ClinicalTrials.gov record for NCT05396300, which also lists 2 linked publications.
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 15 Jul 2026.