Actively Recruiting
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) for CEA Positive Advanced Lung Cancer
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-01-10
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer is a leading cause of illness and death worldwide, with non-small cell lung cancer (NSCLC) making up 80%-85% of cases. Most patients are diagnosed at an advanced stage and face poor outcomes, with low 5-year survival rates. This clinical trial focuses on advanced lung cancer patients who have tumors positive for CEACAM5 (CEA), a tumor marker found in various cancers, including lung cancer. Researchers aim to evaluate a new CAR-T cell therapy designed to target CEA-positive advanced lung cancer and improve treatment effects by enhancing the ability and survival of CAR-T cells in the body. This is a phase 1, single-arm, open-label study using a dose-escalation and dose-extension design to assess the safety, effectiveness, and behavior of CAR-T cell preparations in patients with CEA-positive advanced lung cancer. Participants will receive pre-treatment with fludarabine and cyclophosphamide for three days, followed by either intravenous or intraperitoneal infusion of the targeted CEA CAR-T cells after 1-2 days of rest. The study will determine a recommended dose for these CAR-T cell preparations for this patient group. Participants will be monitored closely for safety and tolerability within 28 days after treatment. Researchers will also evaluate disease control and remission rates at 3 months, as well as survival benefits over 2 years. The study includes ongoing assessments of CAR-T cell pharmacokinetics and pharmacodynamics in the body for up to 2 years. Throughout the study, patients will undergo clinical evaluations, imaging, and laboratory tests to track treatment effects and side effects, with a total participation duration extending up to two years.
CONDITIONS
Brief 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, male or female
- Histologically or pathologically confirmed advanced, metastatic, or recurrent lung cancer, including non-small cell and small cell lung cancer
- Disease progression or intolerance after at least second-line standard therapy, including targeted therapy for driver gene positive NSCLC or platinum-containing chemotherapy for driver negative NSCLC or SCLC
- Tumor samples tested positive for CEA (≥10% positive staining) within 3 months, or serum CEA over 10 ug/L if tumor testing is older than 3 months
- At least one measurable lesion per RECIST 1.1 criteria, with extranodal lesion length ≥10mm or lymph node short diameter ≥15mm
- ECOG performance status score between 0 and 2
- Expected survival time longer than 12 weeks
- No serious mental disorders
- Adequate vital organ function including blood counts, cardiac function, renal and liver function, and blood oxygen saturation > 92%
- Eligible for simple or intravenous blood collection without contraindications
- Agreement to use reliable contraception for 1 year from consent to CAR T infusion
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Central nervous system or meningeal metastasis with symptoms or uncontrolled disease
- Participation in other clinical trials within 1 month before screening
- Receipt of live attenuated vaccine within 4 weeks before screening
- Recent chemotherapy, targeted therapy, or investigational agents within 14 days or 5 half-lives before screening
- Active or uncontrollable infection requiring systemic treatment
- Tumor compressing trachea or major blood vessels with high risk
- Large uncontrollable fluid accumulation in serous cavities
- Unresolved toxicity from prior antitumor therapy except alopecia or peripheral neuropathy
- Severe heart conditions including advanced congestive heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune diseases or need for long-term immunosuppressive therapy
- Other untreated malignant tumors within past 3 years except certain skin and cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Women who are pregnant or breastfeeding
- Other conditions deemed unsuitable by researchers for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants who meet transfusion or reinfusion criteria will receive pre-treatment with chemotherapy drugs fludarabine and cyclophosphamide for 3 days, rest for 1 to 2 days, followed by intravenous or intraperitoneal targeted CEA CAR-T cell therapy.
Multiple visits during pre-treatment and CAR-T infusion period
Duration - Up to 2 years
Participants are monitored for safety, efficacy, and pharmacokinetics of CAR-T cells after treatment.
Regular follow-up visits over 2 years
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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