Targeting CEA in Advanced Lung Cancer with CAR-T Therapy

Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer

This study is testing a new CAR-T therapy for people with advanced lung cancer to see if it can help them after other treatments have failed.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chongqing Precision Biotech Co., Ltd (industry)
• Drugs / interventions: CAR T, chemotherapy, immunotherapy, CAR-T
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06768151 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CAR-T cell preparations targeting the CEA marker in patients with advanced lung cancer. It is a single-arm, open-label study that employs a dose-ascending and dose-extending methodology to determine the recommended dose for CEA positive patients. The trial aims to observe the pharmacokinetic characteristics of the CAR-T cells and their potential to improve outcomes in this patient population. The study focuses on patients who have progressed after standard therapies, making it a critical intervention for those with limited options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced, metastatic, or recurrent lung cancer that is CEA positive.

Not a fit: Patients who have not undergone at least second-line standard therapy or those with CEA negative tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced lung cancer.

How similar studies have performed: Previous studies targeting CEA with CAR-T cells have shown some promise, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old, male or female;
2. histologically or pathologically confirmed advanced, metastatic or recurrent lung cancer, including non-small cell lung cancer and small cell lung cancer;
3. Progression or intolerance (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) after receiving at least second-line standard therapy, patients with driver gene positive non-small cell lung cancer need to receive corresponding targeted therapy for disease progression or intolerance. Patients with driver negative non-small cell lung cancer or small cell lung cancer need to receive platinum-containing chemotherapy for disease progression or intolerance;
4. Immunohistochemical staining of tumor samples within 3 months confirmed CEA positive (clear membrane staining, positive rate ≥10%); If the immunohistochemical results of tumor samples are more than 3 months from the time of screening (clear membrane staining, positive rate ≥10%), the patient's serum CEA should exceed 10ug/L.
5. There is at least one evaluable lesion according to RECIST 1.1 criteria, and the length of the extranodal lesion should be ≥10mm; For nodular lesions, the short diameter of the lymph node should be ≥15mm.
6. ECOG score 0-2 points ;
7. The expected survival time is more than 12 weeks;
8. no serious mental disorders;
9. Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:

   1. Blood routine: Neutrophils \> 1.0×109/L, platelet \> 75×109/L, hemoglobin \> 80g/L;
   2. Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
   3. Renal function: serum creatinine ≤2.0×ULN;
   4. Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0×ULN);
   5. Total bilirubin ≤2.0×ULN;
   6. Blood oxygen saturation in non-oxygen state \> 92%.
10. Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;
11. The subject agrees to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the CAR T cell infusion;
12. The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.

Exclusion Criteria:

1. Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms at the time of screening, or with other evidence that the central nervous system metastasis or meningeal metastasis was not controlled, and the investigators judged that they were not suitable for inclusion;
2. Participating in other clinical studies within 1 month before screening;
3. Received live attenuated vaccine within 4 weeks prior to screening;
4. have received any of the following anti-tumor therapies prior to screening: chemotherapy, targeted therapy, or other investigational agents within 14 days or at least 5 half-lives, whichever is shorter;
5. There is an active infection or uncontrollable infection that requires systemic treatment;
6. The tumor compresses the trachea or important large blood vessels, and the risk is greater as assessed by researchers;
7. There is a large number of uncontrollable fluid accumulation in the serous cavity;
8. Toxicity of previous antitumor therapy has not improved to baseline level or ≤ grade 1, except for alopecia or peripheral neuropathy;
9. Have any of the following heart conditions:

   1. New York Heart Association (NYHA) Stage III or IV congestive heart failure;
   2. Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;
   3. A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
   4. History of severe non-ischemic cardiomyopathy;
10. Patients with active autoimmune diseases, or other patients requiring long-term immunosuppressive therapy;
11. Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;
12. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive;
13. Women who are pregnant or breastfeeding;
14. Circumstances deemed unsuitable for participation in the study by other researchers.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Chu Qian, MD

Conditions: Advanced Lung Cancer, CEA, CAR-T