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New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07250386
What this study is testing
What is CEA-targeted CAR-T (Intravenous)?
CEA-targeted CAR-T (Intravenous) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc (advanced non-small cell 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
- Aged 18 years or older, of any gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
- Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy...
- CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate...
- At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm...
You likely can't join if
- Clinical symptoms of CNS metastasis or meningeal metastasis at screening, or other evidence suggesting that CNS metastasis or meningeal metastasis is...
- Participation in other clinical trials within 4 weeks prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of chemotherapy, targeted therapy, or other experimental drugs within 14 days or at least 5 half-lives (whichever is shorter) prior to...
- Active or uncontrolled infection requiring systemic treatment.
- Tumor compression of the trachea or major blood vessels, with significant risk as assessed by the investigator.
See the full eligibility criteria
- Aged 18 years or older, of any gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
- Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate ≥10%). If the IHC result is more than 3 months old, serum CEA must be...
- At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm for lymph node lesions. Malignant pleural effusion is acceptable for...
- For patients with malignant pleural effusion, accurate volume assessment of pleural effusion by imaging (CT or MRI) and cytological or thoracoscopic biopsy confirmation of malignant pleural effusion.
- ECOG performance status of 0-2.
- Life expectancy of 12 weeks or more.
- No serious psychiatric disorders.
- The following organ function criteria should be met unless otherwise specified:
- Hematology: White blood cell count \>2.0×10\^9/L, neutrophils \>1.0×10\^9/L, lymphocytes \>0.5×10\^9/L, platelets \>50×10\^9/L, hemoglobin \>80 g/L.
- Cardiac function: Echocardiography showing ejection fraction ≥50%, with no significant abnormalities on ECG.
- Renal function: Serum creatinine ≤2.0×ULN.
- Liver function: ALT and AST ≤3.0×ULN (≤5.0×ULN for those with liver tumor infiltration).
- Total bilirubin ≤2.0×ULN.
- Oxygen saturation \>92% without supplemental oxygen.
- Eligible for single or venous blood collection with no contraindications to cell collection.
- Consent to use a reliable and effective method of contraception for 1 year after CAR-T cell infusion (excluding the rhythm method).
- The participant or their authorized guardian agrees to participate in the clinical trial and signs the informed consent form (ICF), indicating an understanding of the trial's purpose and procedures.
- Clinical symptoms of CNS metastasis or meningeal metastasis at screening, or other evidence suggesting that CNS metastasis or meningeal metastasis is uncontrolled, as determined by the investigator.
- Participation in other clinical trials within 4 weeks prior to screening.
- Receipt of a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of chemotherapy, targeted therapy, or other experimental drugs within 14 days or at least 5 half-lives (whichever is shorter) prior to screening.
- Active or uncontrolled infection requiring systemic treatment.
- Tumor compression of the trachea or major blood vessels, with significant risk as assessed by the investigator.
- History of any of the following cardiac diseases:
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening.
- Clinically significant ventricular arrhythmias or unexplained syncope (except those caused by vasovagal or dehydration).
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune disease or other conditions requiring long-term immunosuppressive therapy.
- History of or concurrent untreated malignancies within 3 years, except for basal cell carcinoma or in situ cervical cancer.
- Positive for HBsAg or HBcAb with HBV DNA levels above the normal range, HCV antibody positive with HCV RNA levels above the normal range, HIV antibody positive, or positive for syphilis.
- Pregnant or breastfeeding women.
- Any other condition that the investigator deems unsuitable for participation in the study.
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.