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New treatment option for Lung Cancer
Official title CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07179692
What this study is testing
What is CEA-targeted CAR-T cells?
CEA-targeted CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung 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 study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.
- 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
- Age ≥ 18 years, no gender restriction;
- Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal...
- Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of...
- Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if...
- At least one evaluable lesion according to RECIST 1.1 criteria;
You likely can't join if
- Clinically symptomatic central nervous system metastasis or meningeal metastasis at screening, or other evidence indicating that central nervous...
- Participation in another clinical trial within 1 month prior to screening.
- Receipt of live attenuated vaccines within 4 weeks prior to screening.
- Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy...
- Active infection requiring systemic treatment or an uncontrolled infection.
- Bowel obstruction, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the last 3 months, or severe...
See the full eligibility criteria
- Age ≥ 18 years, no gender restriction;
- Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, and...
- Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment options;
- Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if the immunohistochemical result is older than 3 months (clear membrane...
- At least one evaluable lesion according to RECIST 1.1 criteria;
- ECOG performance status of 0-2;
- Expected survival of ≥ 12 weeks;
- No severe psychiatric disorders;
- Unless otherwise specified, the following important organ function criteria must be met:
- Hematology: 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 \> 90 g/L;
- Cardiac function: Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities;
- Renal function: Serum creatinine ≤ 2.0 × ULN;
- Liver function: ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration);
- Total bilirubin ≤ 2.0 × ULN;
- Oxygen saturation \> 92% without supplemental oxygen;
- Eligible for single or venous blood collection, and no contraindications for cell collection;
- The subject agrees to use reliable and effective contraception methods from the time of signing the informed consent form until 1 year after CAR-T cell infusion (excluding rhythm method);
- The subject or their authorized guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to...
- Clinically symptomatic central nervous system metastasis or meningeal metastasis at screening, or other evidence indicating that central nervous system or meningeal metastasis has not been controlled, as determined by...
- Participation in another clinical trial within 1 month prior to screening.
- Receipt of live attenuated vaccines within 4 weeks prior to screening.
- Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments.
- Active infection requiring systemic treatment or an uncontrolled infection.
- Bowel obstruction, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within the last 3 months, or severe gastrointestinal conditions such as severe gastric or duodenal ulcers, severe...
- Toxicity from prior anti-tumor treatments has not improved to baseline levels or ≤ grade 1, except for alopecia or peripheral neuropathy.
- Any of the following cardiac conditions:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to enrollment;
- Clinically significant ventricular arrhythmias, or history of unexplained syncope (excluding cases due to vasovagal or dehydration);
- Severe non-ischemic cardiomyopathy.
- Active autoimmune diseases or other conditions requiring long-term use of immunosuppressive therapy.
- History of another malignancy within the past 3 years, excluding treated and stable 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 above the normal range; positive for hepatitis C virus (HCV) antibodies with...
- Pregnant or breastfeeding women.
- Any other conditions that, in the opinion of the investigator, make the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 Hefei, Anhui, 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.