Actively Recruiting
Clinical Study of Targeted CEA CAR-T Cell Therapy for CEA Positive Advanced Lung Cancer
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-01-10
48
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer, especially non-small cell lung cancer (NSCLC), accounts for most lung cancer cases and often has a poor outlook due to late diagnosis. This trial focuses on patients with advanced lung cancer that tests positive for CEACAM5 (CEA), a tumor marker found in various cancers including lung cancer. Researchers are studying a new treatment involving CAR T cell therapy designed to target CEA-positive lung cancer cells, aiming to improve the killing and survival ability of these cells in the body by optimizing the CAR structure and culture methods. The trial is a single-arm, open-label, phase 1 study using an enhanced 3+3 dose-escalation and extension design. Participants who meet transfusion criteria will receive pre-treatment with fludarabine and cyclophosphamide for three days, followed by intravenous CEA CAR-T therapy after 1-2 days of rest. Those who meet reinfusion criteria may receive the same pre-treatment and then intraperitoneal reinfusion of targeted CEA CAR-T therapy. The study aims to find the recommended dose and observe safety, efficacy, and pharmacokinetics of the CAR T cell preparation. Participants will undergo evaluations including tumor assessments using RECIST 1.1 criteria, ECOG performance scoring, laboratory tests for organ function, and immunohistochemical staining to confirm CEA positivity. Safety and tolerability of the CAR T cell treatment will be monitored over 28 days following infusion. The study requires participants to have an expected survival time over 12 weeks and involves informed consent, contraception use, and agreement to clinical trial procedures.
CONDITIONS
Official Title
A Clinical Trial of CEA Targeting CAR-T for CEA Positive Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically or pathologically confirmed advanced, metastatic, or recurrent lung cancer, including non-small cell and small cell lung cancer
- Disease progression or intolerance to at least second-line standard therapy; patients with driver gene positive NSCLC must have had targeted therapy, others must have had platinum-containing chemotherapy
- Tumor samples within 3 months showing CEA positivity with at least 10% positive rate; if older than 3 months, serum CEA must exceed 10 ug/L
- At least one measurable lesion per RECIST 1.1, extranodal lesion length at least 10 mm, or lymph node short diameter at least 15 mm
- ECOG performance status score between 0 and 2
- Expected survival time over 12 weeks
- No serious mental disorders
- Satisfactory vital organ function including neutrophils >1.0x10^9/L, platelets >75x10^9/L, hemoglobin >80 g/L, cardiac ejection fraction ≥50%, serum creatinine ≤2.0 times upper limit of normal, ALT and AST ≤3.0 times upper limit (or ≤5.0 with liver tumor infiltration), total bilirubin ≤2.0 times upper limit, and blood oxygen saturation >92% without oxygen
- Eligible for simple or intravenous blood collection without contraindications
- Agree to use reliable contraception for 1 year from consent to CAR T cell infusion
- Provide informed consent and agree to participate in the study
You will not qualify if you...
- Central nervous system metastasis or meningeal metastasis with clinical symptoms or uncontrolled status
- Participation in other clinical trials within 1 month before screening
- Receipt of live attenuated vaccine within 4 weeks before screening
- Anti-tumor therapies such as chemotherapy, targeted therapy, or investigational agents within 14 days or 5 half-lives before screening
- Active or uncontrolled infections requiring systemic treatment
- Tumor compressing trachea or major blood vessels with high risk as assessed by researchers
- Large uncontrollable fluid accumulation in serous cavities
- Toxicity from prior anti-tumor therapy not improved to baseline or grade ≤1 (except alopecia or peripheral neuropathy)
- Severe heart conditions including NYHA Class III/IV heart failure, recent myocardial infarction or coronary artery bypass within 6 months, significant ventricular arrhythmias, unexplained syncope, or severe non-ischemic cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppression
- Other untreated malignant tumors within past 3 years except certain skin and cervical cancers
- Positive hepatitis B, hepatitis C, HIV, or syphilis tests with abnormal viral levels
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
C
Chu Qian, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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