Colorectal CancerPhase 1NCT06821048
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
A Phase 1 study testing Intraperitoneal infusion of FAST CEA-targeted CAR-T in people with Colorectal Cancer and Stomach Cancer, 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 FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Stomach Cancer, Pancreatic Cancer
- What is being tested?
- Intraperitoneal infusion of FAST CEA-targeted CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 1 Dec 2027
- 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
- Subjects must meet all the following criteria to be eligible for the study:
- Age≥18 years, regardless of gender.
- Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, or cholangiocarcinoma.
- Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a lack of effective treatment options.
- Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%); if the immunohistochemical result of the tumor sample is more than 3 months old at the time of screening (distinct membrane staining with a positivity rate of≥10%), the patient's serum CEA must exceed 10µg/L.
- At least one evaluable lesion according to RECIST 1.1 criteria.
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- ECOG score of 0-2 (Appendix 2).
- No severe psychiatric disorders.
- Unless specifically stated otherwise, subjects' major organ functions must meet the following conditions:
- Blood routine: WBC>2.0×109/L, neutrophils>0.8×109/L, lymphocytes>0.5×109/L, platelets>50×109/L, hemoglobin>90g/L;
- Cardiac function: Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram;
- Renal function: Serum creatinine≤2.0×ULN;
- Liver function: ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present);
- Total bilirubin≤2.0×ULN;
- Oxygen saturation>92% without supplemental oxygen. 9. Eligible for apheresis or venous blood collection, with no contraindications for cell collection.
- 10. Subjects agree to use reliable and effective contraceptive methods from signing the informed consent form until 1 year after receiving CAR-T cell infusion (excluding natural family planning methods).
- 11. The patient or their guardian agree to participate in this clinical trial and signs the ICF, indicating an understanding of the trial's purpose and procedures and willingness to participate.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- Clinically symptomatic central nervous system or leptomeningeal metastasis at the time of screening, or other evidence suggesting that central nervous system or leptomeningeal metastases are not controlled, as judged unsuitable for inclusion by the investigator.
- Participation in another clinical study within 1 month prior to screening.
- Receipt of live attenuated vaccines within 4 weeks prior to screening.
- Receipt of the following anti-tumor treatments before screening: Chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter).
- Presence of active or uncontrolled infections requiring systemic treatment.
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- Patients with intestinal obstruction, active gastrointestinal bleeding, a history of major gastrointestinal bleeding within 3 months, severe gastroduodenal ulcers, or severe gastrointestinal inflammation such as ulcerative colitis.
- Toxicity from previous anti-tumor therapy that has not improved to baseline levels or≤Grade 1, except for alopecia or peripheral neuropathy.
- Presence of any of the following cardiac conditions:
- New York Heart Association (NYHA) Stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;
- Clinically significant ventricular arrhythmia or history of unexplained syncope (excluding vasovagal or dehydration-related causes);
- History of severe non-ischemic cardiomyopathy.
- Presence of active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy.
- Diagnosis of another untreated malignancy within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA levels exceeding the normal range; positive for hepatitis C virus (HCV) antibodies with peripheral blood HCV RNA levels exceeding the normal range; positive for human immunodeficiency virus (HIV) antibodies; or positive syphilis test.
- Pregnant or breastfeeding women.
- Any other conditions deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yang Gao, MD contact
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hangzhou, Zhejiang, 310006
Weijia Fang, MD, 86-0571-87237587, weijiafang@zju.edu.cn
About this study
Official title: A Phase I Clinical Study of Anti-CEA CAR-T (PTC13) 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 FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
Read the detailed description
This is a single-center, open-label, dose-escalation and expansion study. The study includes one intraperitoneal infusion group only, with four dose levels: 2.0×10⁵ CAR+ cells/kg, 3.0×10⁵ CAR+ cells/kg, 4.0×10⁵ CAR+ cells/kg, and 5.0×10⁵ CAR+ cells/kg. Each dose level will initially enroll 3 to 6 patients using a standard 3+3 design to preliminarily evaluate safety and efficacy. Based on the comprehensive assessment by investigators and the technical collaborators, 1 to 2 recommended dose levels will be selected for dose expansion. In the expansion phase, an additional 6 to 12 patients will be enrolled to further evaluate safety and efficacy. The total planned enrollment is approximately 18 to 36 patients. Priority will be given to patients with peritoneal metastases from colorectal cancer.
- Being tested
- Intraperitoneal infusion of FAST CEA-targeted CAR-T
- Keywords
- FAST CAR-T, CEA-positive advanced malignant solid tumors
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13) | Experimental | Intraperitoneal infusion of FAST CEA-targeted CAR-T cells (PTC13) by 4 dose levels Receives: Biological: Intraperitoneal infusion of FAST CEA-targeted CAR-T |
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
Incidence and proportion of adverse events during the trial (evaluated per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0) and ASTCT criteria)
Measured: 28 days
Obtain the maximum tolerated dose of CEA-CAR-T cells
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
including complete response (CR), partial response (PR) and stable disease (SD)
Measured: 3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies
Tumor markers including CEA、 CA199、 CA125
Measured: 3 months
Pharmacokinetic of CAR-T cells (Cmax)
The highest concentration of CAR-T cells in peripheral blood post-administration.
Measured: 1 year
Pharmacokinetic of CAR-T cells (Tmax)
The time to reach the highest concentration
Measured: 1 year
Pharmacokinetic of CAR-T cells (AUC28d/90d)
Area under the curve at 28 days/90 days
Measured: 1 year
Pharmacodynamic of CAR-T cells
Levels of free CEA in peripheral blood at various time points.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start24 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821048
- Sponsor's protocol ID
- PBC039V1.4
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2025
- Last updated
- 23 Jan 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 23 Jan 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 (PTC13) Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06821048
- Acronym / sponsor ID
- PBC039V1.4
- Keywords
- FAST CAR-T, CEA-positive advanced malignant solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Weijia Fang, MDUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Feb 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.
This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
Detailed description
This is a single-center, open-label, dose-escalation and expansion study. The study includes one intraperitoneal infusion group only, with four dose levels: 2.0×10⁵ CAR+ cells/kg, 3.0×10⁵ CAR+ cells/kg, 4.0×10⁵ CAR+ cells/kg, and 5.0×10⁵ CAR+ cells/kg. Each dose level will initially enroll 3 to 6 patients using a standard 3+3 design to preliminarily evaluate safety and efficacy. Based on the comprehensive assessment by investigators and the technical collaborators, 1 to 2 recommended dose levels will be selected for dose expansion. In the expansion phase, an additional 6 to 12 patients will be enrolled to further evaluate safety and efficacy. The total planned enrollment is approximately 18 to 36 patients. Priority will be given to patients with peritoneal metastases from colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13) | Experimental | Biological: Intraperitoneal infusion of FAST CEA-targeted CAR-TIntraperitoneal infusion of FAST CEA-targeted CAR-T cells (PTC13) by 4 dose levels |
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, regardless of gender.
- Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, or cholangiocarcinoma.
- Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a lack of effective treatment options.
- Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%); if the immunohistochemical result of the tumor sample is more than 3 months old at the time of screening (distinct membrane staining with a positivity rate of≥10%), the patient's serum CEA must exceed 10µg/L.
- At least one evaluable lesion according to RECIST 1.1 criteria.
Key exclusion criteria (18 listed)
- Clinically symptomatic central nervous system or leptomeningeal metastasis at the time of screening, or other evidence suggesting that central nervous system or leptomeningeal metastases are not controlled, as judged unsuitable for inclusion by the investigator.
- Participation in another clinical study within 1 month prior to screening.
- Receipt of live attenuated vaccines within 4 weeks prior to screening.
- Receipt of the following anti-tumor treatments before screening: Chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter).
- Presence of 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 |
|---|---|---|
| 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 (PTC13) |
Primary outcome
Incidence of Adverse events after CEA-CAR-T cells infusion
Time frame: 28 days
Incidence and proportion of adverse events during the trial (evaluated per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0) and ASTCT criteria)
Obtain the maximum tolerated dose of CEA-CAR-T cells
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
Time frame: 3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignancies
Time frame: 3 months
Pharmacokinetic of CAR-T cells (Cmax)
Time frame: 1 year
Pharmacokinetic of CAR-T cells (Tmax)
Time frame: 1 year
Pharmacokinetic of CAR-T cells (AUC28d/90d)
Time frame: 1 year
Pharmacodynamic of CAR-T cells
Time frame: 1 year
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 23 Jan 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.
Yang Gao, MD contact
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 in people with Colorectal Cancer and Stomach Cancer, 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 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: looking for participants now, as of the sponsor's last update on 23 Jan 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?
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 Weijia Fang, MD (86-0571-87237587, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after CEA-CAR-T cells infusion (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 23 Jan 2026.