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Clinical Trial Record

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Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors

2024-07-24

2026-06-01

2027-12-01

18

Study Overview

Study of CEA Targeting CAR-T (PTC13) 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.

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.

  • Colorectal Cancer
  • Stomach Cancer
  • Pancreatic Cancer
  • Metastatic Cancer
  • BIOLOGICAL: Intraperitoneal infusion of FAST CEA-targeted CAR-T
  • PBC039V1.4

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-02-04  

N/A  

2025-07-30  

2025-02-08  

N/A  

2025-08-05  

2025-02-11  

N/A  

2025-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Intraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13)

Intraperitoneal infusion of FAST CEA-targeted CAR-T cells (PTC13) by 4 dose levels

BIOLOGICAL: Intraperitoneal infusion of FAST CEA-targeted CAR-T

  • 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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of Adverse events after CEA-CAR-T cells infusionIncidence 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)28 days
Obtain the maximum tolerated dose of CEA-CAR-T cellsDose-limiting toxicity after cell infusion28 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate of CAR-T cell preparations in CEA-positive advanced malignanciesincluding complete response (CR), partial response (PR) and stable disease (SD)3 months
Changes in serum tumor markers of CAR-T cell preparations in CEA-positive advanced malignanciesTumor markers including CEA、 CA199、 CA1253 months
Pharmacokinetic of CAR-T cells (Cmax)The highest concentration of CAR-T cells in peripheral blood post-administration.1 year
Pharmacokinetic of CAR-T cells (Tmax)The time to reach the highest concentration1 year
Pharmacokinetic of CAR-T cells (AUC28d/90d)Area under the curve at 28 days/90 days1 year
Pharmacodynamic of CAR-T cellsLevels of free CEA in peripheral blood at various time points.1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Weijia Fang, MD

Phone Number: 86-0571-87237587

Email: weijiafang@zju.edu.cn

Study Contact Backup

Name: Yang Gao, MD

Phone Number:

Email: gaoyang954@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    Subjects must meet all the following criteria to be eligible for the study:
    1. Age≥18 years, regardless of gender. 2. 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. 3. 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. 4. 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. 5. At least one evaluable lesion according to RECIST 1.1 criteria. 6. ECOG score of 0-2 (Appendix 2). 7. No severe psychiatric disorders. 8. Unless specifically stated otherwise, subjects' major organ functions must meet the following conditions:
    1. Blood routine: WBC>2.0×109/L, neutrophils>0.8×109/L, lymphocytes>0.5×109/L, platelets>50×109/L, hemoglobin>90g/L; 2. Cardiac function: Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram; 3. Renal function: Serum creatinine≤2.0×ULN; 4. Liver function: ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present); 5. Total bilirubin≤2.0×ULN; 6. 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.
    Exclusion Criteria:
    Subjects meeting any of the following criteria will be excluded from the study:
    1. 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. 2. Participation in another clinical study within 1 month prior to screening. 3. Receipt of live attenuated vaccines within 4 weeks prior to screening. 4. 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). 5. Presence of active or uncontrolled infections requiring systemic treatment. 6. 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. 7. Toxicity from previous anti-tumor therapy that has not improved to baseline levels or≤Grade 1, except for alopecia or peripheral neuropathy. 8. Presence of any of the following cardiac conditions:
    1. New York Heart Association (NYHA) Stage III or IV congestive heart failure; 2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment; 3. Clinically significant ventricular arrhythmia or history of unexplained syncope (excluding vasovagal or dehydration-related causes); 4. History of severe non-ischemic cardiomyopathy. 9. Presence of active autoimmune diseases or other conditions requiring long-term immunosuppressive therapy. 10. Diagnosis of another untreated malignancy within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin. 11. 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. 12. Pregnant or breastfeeding women. 13. Any other conditions deemed unsuitable for participation in the study by the investigator.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Chongqing Precision Biotech Co., Ltd
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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