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New treatment option for Colorectal Cancer
Official title Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06821048
What this study is testing
What is Intraperitoneal infusion of FAST CEA-targeted CAR-T?
Intraperitoneal infusion of FAST CEA-targeted CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a...
- Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%)...
You likely can't join if
- people 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...
- 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...
- Presence of active or uncontrolled infections requiring systemic treatment.
See the full eligibility criteria
- people 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...
- 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...
- At least one evaluable lesion according to RECIST 1.1 criteria.
- ECOG score of 0-2 (Appendix 2).
- No severe psychiatric disorders.
- Unless specifically stated otherwise, people' 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\. people agree to use reliable and effective contraceptive...
- people 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...
- 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.
- 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...
- 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...
- Pregnant or breastfeeding women.
- Any other conditions deemed unsuitable for participation in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.