Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted CAR-T Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-26
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CEA-targeted CAR-T cell therapy in patients with advanced solid tumors that test positive for carcinoembryonic antigen (CEA), including non-small cell lung cancer and breast cancer. This single-arm, open-label study focuses on patients whose disease has progressed or who cannot tolerate standard treatments after at least two prior therapies. The study aims to find the best dose and infusion schedule for this therapy and to observe its effects in these advanced cancers. Patients will be divided into two groups based on the infusion method: intravenous infusion or intrapleural infusion. Each group undergoes a dose-escalation phase, where small groups receive increasing doses of CAR-T cells to identify a recommended dose, followed by a dose-expansion phase to further assess safety and preliminary efficacy. Before receiving the CAR-T cell infusion, participants will have conditioning therapy with Fludarabine and Cyclophosphamide. The CAR-T cells are administered at doses ranging from 2 to 6 x 10^5 cells per kilogram. During the study, participants will be closely monitored from infusion through three months for safety and tolerability, including the pharmacokinetics of the CAR-T cells. Effectiveness will be assessed up to two years, including measures such as disease control rate, response rate, duration of response, progression-free survival, and overall survival. Participants will undergo evaluations including imaging scans, blood tests, and clinical assessments to track their condition and the therapy's impact. The total participation may last up to two years, with ongoing follow-up to observe long-term outcomes.
CONDITIONS
Brief Title
A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, 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 such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- CEA positivity confirmed by immunohistochemistry within 3 months or serum CEA above 10 ng/mL if older
- At least one evaluable lesion meeting size criteria according to RECIST 1.1
- For malignant pleural effusion, confirmed by imaging and biopsy
- ECOG performance status of 0-2
- Life expectancy of 12 weeks or more
- No serious psychiatric disorders
- Meet specified hematology, cardiac, renal, liver function, and oxygen saturation criteria
- Eligible for blood collection without contraindications
- Use of effective contraception for 1 year after infusion
- Signed informed consent form
You will not qualify if you...
- Symptoms or uncontrolled central nervous system metastasis or meningeal metastasis
- Participation in other clinical trials within 4 weeks prior
- Receipt of live attenuated vaccine within 4 weeks prior
- Receipt of chemotherapy, targeted therapy, or experimental drugs within 14 days or 5 half-lives before screening
- Active or uncontrolled infection needing systemic treatment
- Tumor compression of trachea or major vessels with significant risk
- History of severe cardiac diseases including NYHA Class III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or severe cardiomyopathy
- Active autoimmune disease or need for long-term immunosuppressive therapy
- Untreated malignancies within 3 years except certain skin or cervical cancers
- Positive tests for hepatitis B or C virus, HIV, or syphilis above normal levels
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
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 - From infusion through Month 3
Participants receive conditioning therapy followed by infusion of CEA-targeted CAR-T cells either intravenously or by intrapleural infusion. Treatment includes dose-escalation and dose-expansion phases to evaluate safety and preliminary efficacy.
Multiple visits during treatment period for infusions and assessments
Duration - Up to 2 years
Participants are monitored for effectiveness and long-term outcomes including response rate, duration of response, progression-free and overall survival.
Regular visits up to 2 years for ongoing assessments
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310017
Actively Recruiting
Research Team
F
Fuming Qiu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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