Status:
RECRUITING
Targeted Anti-CEA CAR-T Immunotherapy for Advanced Lung Cancer
Lead Sponsor:
Chongqing Precision Biotech Co., Ltd
Conditions:
Advanced Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Lung cancer is the leading cause of morbidity and mortality in the world, of which 80%-85% are non-small cell lung cancer (NSCLC). Most patients with NSCLC are at the advanced stage of diagnosis and h...
Detailed Description
This study is a single-arm, open, enhanced 3+3 dose-ascending + dose-extending clinical study, aiming to evaluate the safety and efficacy of CAR T cell preparations, initially observe and study the ph...
Eligibility Criteria
Inclusion
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- Participants must meet all of the following criteria to be eligible for enrollment:
- Age ≥18 years, regardless of gender.
- Histologically or cytologically confirmed advanced, metastatic, or recurrent lung cancer, including both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
- Disease progression or intolerance after receiving standard therapies (including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy):
- NSCLC: Disease progression or intolerance after at least second-line standard therapy.
- SCLC: Disease progression or intolerance after at least first-line standard therapy.
- For patients with pleural effusion assigned to the intrapleural infusion group, the pleural effusion volume and characteristics must be accurately assessed by imaging (chest CT or X-ray) combined with cytology. Malignant pleural effusion must be confirmed by the presence of tumor cells in pleural fluid cytology.
- Tumor CEA positivity confirmed by immunohistochemistry (IHC) within 3 months prior to screening, defined as distinct membranous staining with ≥10% positivity. If the tumor sample was assessed more than 3 months prior to screening, a serum CEA level \>10 µg/L is required.
- At least one measurable lesion according to RECIST 1.1 criteria:
- Non-nodal lesions: longest diameter ≥10 mm. Lymph node lesions: short axis ≥15 mm.
- ECOG performance status score of 0 to 2 .
- Estimated life expectancy of more than 12 weeks.
- No severe psychiatric disorders.
- Adequate major organ function unless otherwise specified, defined as follows:
- Hematology: WBC \> 2.0 × 10⁹/L; Neutrophils \> 1.0 × 10⁹/L; Lymphocytes \> 0.5 × 10⁹/L; Platelets \> 50 × 10⁹/L; Hemoglobin \> 80 g/L.
- Cardiac function: LVEF ≥ 50% on echocardiogram; no significant abnormalities on ECG.
- Renal function: Serum creatinine ≤ 2.0 × ULN. Hepatic function: ALT and AST ≤ 3.0 × ULN (≤ 5.0 × ULN if there is hepatic tumor infiltration).
- Total bilirubin ≤ 2.0 × ULN. Peripheral oxygen saturation \>92% in room air.
- Eligible for leukapheresis or venous blood collection, with no contraindications to cell collection.
- Willing to use reliable and effective contraception methods (excluding rhythm method) from informed consent signing until one year after CAR-T cell infusion.
- Participant or legally authorized representative has voluntarily signed the informed consent form (ICF), indicating understanding of the study objectives and procedures and willingness to participate in the clinical trial.
Exclusion
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- Participants who meet any of the following criteria will be excluded from the study:
- Clinically symptomatic central nervous system (CNS) metastasis or meningeal metastasis at screening, or other evidence suggesting the presence of uncontrolled CNS or meningeal metastasis, as judged by the investigator.
- Participation in any other clinical trial within 1 month prior to screening.
- Vaccination with a live attenuated vaccine within 4 weeks prior to screening.
- Receipt of the following anti-tumor treatments within 4 weeks prior to screening: chemotherapy, targeted therapy, or any experimental drug treatment within 14 days or at least 5 half-lives (whichever is shorter).
- Active infection requiring systemic treatment or any uncontrolled infection.
- Tumor compression of the trachea or major blood vessels, as determined by the investigator to carry a high risk.
- History of the following cardiac conditions:
- NYHA Class III or IV congestive heart failure. Myocardial infarction or coronary artery bypass graft (CABG) surgery within 6 months prior to enrollment.
- Clinically significant ventricular arrhythmias or a history of unexplained syncope (except due to vasovagal or dehydration-related causes).
- History of severe non-ischemic cardiomyopathy.
- Active autoimmune disease or any condition requiring long-term immunosuppressive therapy.
- History of any other untreated malignancy within the past 3 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above normal range; positive for hepatitis C antibody with peripheral blood HCV RNA levels above normal range; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test.
- Pregnancy or breastfeeding women.
- Any other condition that the investigator deems unsuitable for participation in the study.
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06992583
Start Date
May 8 2025
End Date
April 30 2028
Last Update
May 28 2025
Active Locations (1)
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1
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210002